Class 2 Device Recall Medtronic InSync II Marquis

• Date Initiated by Firm: February 09, 2005
• Date Posted: March 11, 2005
• Recall Status: Terminated on December 28, 2006
• Recall Number: Z-0604-05
• Recall Event ID: 31142
• PMA Number: P010031S005
• Product Classification: Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - Product Code NIK
• Product: Medtronic InSync II Marquis, model 7289 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy 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 7289 InSync II Marquis (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.) S-Series: PRJ600001 - PRJ609639S and PRJ614813 - PRJ614815S
• 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: 7235 ONLY distributed within US
• 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 = NIK and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT; PMAs with Product Code = NIK and Original Applicant = Medtronic, Inc.