Class 2 Device Recall Medtronic Marquis DR

• Date Initiated by Firm: February 09, 2005
• Date Posted: March 11, 2005
• Recall Status: Terminated on December 28, 2006
• Recall Number: Z-0599-05
• Recall Event ID: 31142
• PMA Number: P980016S023
• Product Classification: Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
• Product: Medtronic Marquis DR, model 7274 Dual 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 7274 Marquis DR (serial numbers listed include all afffected devices but may include some unaffected devices. Patients are recommended to check with their doctor for exact serial numbers affected.) H-Series: PKC100001H - PKC138887H and PKC142234H. R-series: PKC200320R - PKC200572R. A-Series: PKC120001S - PKC120092S and PKC600001S - PKC617090S.
• Recalling Firm/ Manufacturer: Medtronic Inc. Cardiac Rhythm Managment; 7000 Central Ave Ne; Fridley MN 55432
• 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: 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: 42,388 total, (34,620 in US & 7,768 OUS)
• Distribution: worldwide
• Total Product Life Cycle: TPLC Device Report

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.

• 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.