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

Model Number PM1210

Device Problems Telemetry Discrepancy (1629); Device Operates Differently Than Expected (2913)

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

Event Date 07/08/2014

Event Type  malfunction  

Event Description

New information indicated the device exhibited lack of radio frequency telemetry because the end of service flag had not been cleared.

Event Description

It was reported that the pulse generator exhibited diagnostics anomaly after an unrelated surgery.The device was exposed to defibrillation and electrocautery.After the elective replacement indicator was reset, normal device function resumed.The patient would be monitored with routine follow-up.

Manufacturer Narrative

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

• Brand Name: ACCENT SR RF OUS
• 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: jennie hamel ; 15900 valley view court; sylmar, CA 91342 ; 8184933462
• MDR Report Key: 4073872
• MDR Text Key: 5799873
• Report Number: 2017865-2014-16854
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2014
• 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: PM1210
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2012
• 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
• Patient Age: 67 YR