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

Model Number PM1210

Device Problem Telemetry Discrepancy (1629)

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

Event Date 04/07/2011

Event Type  Injury  

Event Description

It was reported that during implant, the pulse generator exhibited intermittent telemetry.The device was not implanted.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.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 found that testing indicated a failure of the rf module.

• Brand Name: ACCENT SR RF OUS
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR, DXY
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view court; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 4191844
• MDR Text Key: 17161051
• Report Number: 2017865-2014-04306
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Model Number: PM1210
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/23/2011
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/07/2011
• Device Age: 1 MO
• Event Location: Other
• Initial Date Manufacturer Received: 04/27/2011
• Initial Date FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2011
• 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 Outcome(s): Required Intervention