MAUDE Adverse Event Report: ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI ACCENT DR RF

Model Number PM2210

Device Problem Telemetry Discrepancy (1629)

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

Event Date 01/20/2012

Event Type  malfunction  

Event Description

It was reported that the pacemaker while still in box exhibited a telemetry rf anomaly.

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.Final analysis confirmed the complaint.

• Brand Name: ACCENT DR RF
• Manufacturer (Section D): ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI; 15900 valley view ct.; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, 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: 4218296
• MDR Text Key: 5076513
• Report Number: 2017865-2014-05293
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2012
• Device Model Number: PM2210
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/24/2012
• Distributor Facility Aware Date: 01/24/2012
• Device Age: 7 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/24/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1