Date Initiated by Firm |
February 09, 2005 |
Date Posted |
March 11, 2005 |
Recall Status1 |
Terminated 3 on December 28, 2006 |
Recall Number |
Z-0601-05 |
Recall Event ID |
31142 |
PMA Number |
P980016S037 |
Product Classification |
Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
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Product |
Medtronic Maximo DR, model 7278 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 7278 Maximo DR (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: PRM800001Q - PRM800123Q. S-Series: PRM600001S - PRM605919S and PRM606025S - PRM606035S |
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
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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.
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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 |
2,542 total, (2,217 in US & 325 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 and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PMAs with Product Code = LWS and Original Applicant = Medtronic, Inc.
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