MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI SUSTAIN XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM2136

Device Problems No Device Output (1435); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2013

Event Type  malfunction  

Event Description

It was reported that the pulse generator exhibited no output.The device was removed and replaced.

Manufacturer Narrative

This historical complaint is being filed as part of a retrospective review of complaint files in response to a recent fda inspection.There is no change to the actual performance of the product and this report only represents an enhancement to the reporting criteria going forward.Eval: analysis was normal.No anomaly was found.

• Brand Name: SUSTAIN XL DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI; 15900 valley view ct.; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI; 15900 valley view ct.; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view ct.; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 4152088
• MDR Text Key: 4927257
• Report Number: 2017865-2014-06347
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Model Number: PM2136
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/20/2013
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/29/2013
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/29/2013
• Initial Date FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1