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Important Safety Information on certain Guidant/Boston Scientific pacemakers and defibrillators - For Health Professionals
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The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Guidant Canada Corporation. Contact the company for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Safety Information on certain Guidant/Boston Scientific pacemakers and defibrillators
June 26, 2006
URGENT MEDICAL DEVICE SAFETY INFORMATION & CORRECTIVE ACTION
Subject: Potential for malfunction in a subset of implantable pacemakers, cardiac resynchronization therapy pacemakers (CRT-Ps), and cardioverter defibrillators (ICDs) manufactured by Guidant Cardiac Rhythm Management (CRM), a Boston Scientific Company
Dear Health Care Professional,
This letter is intended to inform you of important safety information regarding the potential for malfunction in a subset of INSIGNIA® and NEXUS® pacemakers, CONTAK RENEWAL® TR/TR 2 CRT-Ps, and VENTAK PRIZM® 2, VITALITY® and VITALITY 2 ICDs. Our records indicate that you have implanted or are monitoring patients with one of these devices.
As a precautionary measure, Guidant has initiated action to retrieve from hospital and sales force inventory all non-implanted devices within this well-defined subset. Consistent with Heart Rhythm Society and Independent Panel (Robert J. Myerburg, MD, chair) recommendations for timely, transparent and responsible actions, Guidant is taking this product retrieval action before our investigation is complete and prior to finalizing patient care recommendations.
Description of Issue
Guidant has recently confirmed five (5) reports of device malfunction associated with the failure of a low-voltage capacitor from a single component supplier. Some capacitors from specific lots may perform in a manner that leads to device malfunction, including intermittent or permanent loss of therapy or premature battery depletion. One device malfunction was discovered at the time of implant, while four devices were implanted and subsequently required replacement. To date, approximately 49,800 devices have been distributed and approximately 27,200 devices have been implanted worldwide.
Clinical Implications
Patients with affected pacemakers or CRT-Ps may experience intermittent or permanent loss of output or telemetry, or premature battery depletion. Patients with affected ICDs may experience inappropriate sensing or premature battery depletion. There have been no reported patient deaths associated with this issue. There have been two reports of pacemaker patients experiencing syncope associated with loss of pacing output.
Projected Rate of Occurrence
We are very early in our investigation and do not have sufficient information to provide a projected rate of occurrence. We are continuing to diligently gather and analyze data to provide physicians with additional information regarding projected rate of occurrence for implanted devices. This information will be provided in a subsequent communication as soon as it is available.
Recommendations
- Physicians are asked to perform an in-clinic follow-up visit as soon as possible for all patients with implanted devices from this subset. A list of patients with susceptible devices specific to your clinic is included with this communication. At this follow-up visit, please look for the following device behaviors, which may be indicative of capacitor malfunction: premature battery depletion, intermittent or permanent loss of therapy or telemetry, fault codes, pacing or sensing abnormalities, or loss of daily measurements. Your local representative can provide additional technical guidance to assist in the evaluation of devices in this subset. Please document and report any observations of abnormal behavior through your local representative or Guidant Technical Services.
- Guidant requests that all non-implanted inventory in this subset be returned to Guidant. Your local sales representative can provide a complete list of device model and serial numbers and is available to coordinate the retrieval process.
Warranty Supplement Program
Guidant's Warranty Supplement Program, subject to certain conditions, provides a no cost replacement device.
Devices Affected
The following models are affected by this communication:
| Device Family | Model Numbers* |
|---|---|
| INSIGNIA | 482, 484, 485, 882, 982, 985, 986, 1190, 1192, 1194, 1195, 1198, 1290, 1291, 1292, 1294, 1295, 1296, 1297, 1298 |
| NEXUS* | 1325, 1326, 1328, 1390, 1392, 1394, 1395, 1398, 1426, 1428, 1432, 1466, 1467, 1468, 1490, 1491, 1492, 1494, 1495 |
| CONTAK RENEWAL TR | H120, H125 |
| CONTAK RENEWAL TR 2 | H140, H145 |
| VENTAK PRIZM 2 | 1860, 1861 |
| VITALITY | 1870, 1871, T125, T127, T135 |
| VITALITY 2 | T165, T167, T175, T177 |
* Note: NEXUS pacemakers are not distributed in Canada.
Further Information
The Heart Rhythm Society's recommended "Advisory Notice" for this communication is attached.
Guidant recognizes the impact of this communication on you and your patients and wants to reassure you that patient safety remains our primary concern. As always, if you have any questions regarding this communication, please contact your local Guidant Canada representative or Guidant Technical Services at 1.800.CARDIAC (227-3422).
Guidant Canada
505 Apple Creek Blvd., Unit 4
Markham, Ontario L3R 5B1
CANADA
Phone: (905) 947-5800 or 1-800-268-4487
Fax: (905) 947-5846 or 1-800-390-3043
Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Tel: The Inspectorate Hotline 1-800-267-9675
Fax : (613) 954-0941
The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.
For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: MHPD_DPSC@hc-sc.gc.ca
Tel: (613) 954-6522
Fax: (613) 952-7738
Sincerely,
original signed by
Scott Kadwell
Country Manager, CRM
Guidant Canada Corporation
Attachment
PHYSICIAN DEVICE ADVISORY NOTICE
Advisory Date: June 26, 2006
| Manufacturer(s) | Guidant CRM, a Boston Scientific Company | ||
| Product(s) | Trade Name INSIGNIA, NEXUS, CONTAK RENEWAL TR, CONTAK RENEWAL TR2, VENTAK PRIZM 2, VITALITY, VITALITY 2 Note: NEXUS pacemakers are not distributed in Canada. |
Model Number 482, 484, 485, 882, 982, 985, 986, 1190, 1192, 1194, 1195, 1198, 1290, 1291, 1292, 1294, 1295, 1296, 1297, 1298, 1325, 1326, 1328, 1390, 1392, 1394, 1395, 1398, 1426, 1428, 1432, 1466, 1467, 1468, 1490, 1491, 1492, 1494, 1495, H120, H125, H140, H145, 1860, 1861, 1870, 1871, T125, T127, T135, T165, T167, T175, T177 |
|
| Manufactured on or before (Date) | Not Applicable | ||
| Performance Failure | Patients with affected pacemakers or CRT-Ps may experience intermittent or permanent loss of output or telemetry, or premature battery depletion. Patients with affected ICDs may experience inappropriate sensing or premature battery depletion. | ||
| Root Cause (if known) | Failure of low-voltage capacitor | ||
| Date Manufacturer Corrected Product Available (if known) | Non-affected product is available | ||
| Has all affected product been retrieved? |  Yes |
 No |
When? Retrieval of non-implanted product in process |
FDA CLASSIFICATION STATUS
| Advisory classification | Class: | Decision Pending |
CLINICAL ACUITY
| (USA) | (Worldwide) | |
|---|---|---|
| a) Total number of units currently implanted | Approximately 13,800 | Approximately 27,200 |
| b) Estimated number of potentially affected devices of this mode worldwide | Approximately 25,400 distributed | Approximately 49,800 distributed |
| c) Estimated incidences of this performance failure over the projected life of the device | Too early to predict | Too early to predict |
| d) Total number with observed Performance Failure | 2 reports to date | 5 reports to date |
| % of Performance Failures d/b x 100 = |
0.008% reported | 0.010% reported |
| e) Mean age of product in implanted population | Not Applicable | Not Applicable |
| f) Patient deaths reported | Yes |
No |
| Number of deaths = | 0 | |
| g) Patient deaths with probable relationship to device failure | Yes |
No |
| Number of deaths = | 0 |
* The data analysis provided in this report was generated by the manufacturer and may be subject to change
DEVICE FUNCTION AT RISK OF PERFORMANCE FAILURE
|
Battery Failure (premature depletion) |
|
CRT (left ventricular pacing) |
|
Diagnostic Data Failure (daily measurements) |
|
Lead Failure |
|
Brady Therapies (lower rate pacing) |
|
Hermeticity or internal component (low-voltage capacitor) |
|
Brady Therapies (runaway pacing) |
|
EMI Susceptibility |
|
Tachy Therapies (ATP) |
|
Telemetry Failure |
|
Tachy Therapies (shock) |
|
Other (specify) |
PATIENT MANAGEMENT RECOMMENDATIONS
| Verify normal device function (at normal follow-up interval) | Yes |
No |
| Verify normal device function (as soon as possible) | Yes |
No |
Specific measures to assess: Premature battery depletion, intermittent or permanent loss of therapy or telemetry, fault codes, pacing or sensing abnormalities, or loss of daily diagnostic measurements |
||
| Programming changes | Required |
Recommended |
If programming changes are required, specify changes:
|
||
| Accelerated device follow-up | Yes |
No |
| Timeline - months: | Not Applicable | |
CONTACT
Guidant Canada Corporation
505 Apple Creek Boulevard, Unit 4
Markham, ON L3R 5B1
Tel: 800.268.4487 or 905.947.5800
Fax: 800.390.3043 or 905.947.5846
Guidant CRM, a Boston Scientific Company
4100 Hamline Avenue North
St. Paul, MN 55112-5798
Tel: 651.582.4000
Fax: 651.582.4166
crmevent@guidant.com
http://www.guidant.com
Guidant Europe S.A., a Boston Scientific Company
Park Lane
Culliganlaan 2B
1831 Diegem
Belgium
Tel: 32.2.714.14.11
Fax: 32.2.714.14.12
eurtechservice@guidant.com
