Date Initiated by Firm | February 09, 2005 |
Date Posted | March 11, 2005 |
Recall Status1 |
Terminated 3 on December 28, 2006 |
Recall Number | Z-0598-05 |
Recall Event ID |
31142 |
PMA Number | P980016S037 |
Product Classification |
Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
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Product | Medtronic Maximo VR, model 7232 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers. |
Code Information |
Model 7232 Maximo VR (serial numbers listed include all affected devices but may include some unaffected devices. Patients are recommended to check with their doctor for exact serial numbers affected.) Q-Series: PRN800001A - PRN800024Q. S-series PRN600001S - PRN602430S and PRN604401S - PRN604831S. |
Recalling Firm/ Manufacturer |
Medtronic Inc. Cardiac Rhythm Managment 7000 Central Ave Ne Fridley MN 55432
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For Additional Information Contact | Tim Samsel 763-514-3149 |
Manufacturer Reason for Recall | Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function. |
FDA Determined Cause 2 | Other |
Action | Medtronic Sales Representatives contacted affected physicians starting 02/10/05 to deliver an Important Patient Management Information. The letter recommended patient managment options including quarterly follow-ups, programming Patient Alert to 'On-High', provide magnet to patients to check device status and inform patients that should they expereicnce warmth in the area surrounding the ICD to seek prompt care. |
Quantity in Commerce | 2,093 total, (1,616 in US & 477 OUS) |
Distribution | worldwide |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = LWS PMAs with Product Code = LWS
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