MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD ACCENT DR RF; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM2210

Device Problem Telemetry Discrepancy (1629)

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

Event Date 03/04/2014

Event Type  malfunction  

Event Description

It was reported that a non-dependent patient presented for a routine follow-up.Upon interrogation, a message indicated the telemetry was disabled.A firmware was downloaded, telemetry was restored.Upon interrogation same message appeared.The patient would return for further testing.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.

• Brand Name: ACCENT DR RF
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view court; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 3794371
• MDR Text Key: 4386551
• Report Number: 2017865-2014-12356
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2014
• Device Model Number: PM2210
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2013
• 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
• Patient Age: 72 YR