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

Model Number PM2210

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332); No Device Output (1435)

Patient Problem Muscle Stimulation (1412)

Event Date 07/29/2014

Event Type  Injury  

Event Description

New information notes device exhibited premature battery depletion and no output.

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

Manufacturer Narrative

Final analysis found that the telemetry coil was dislodged from its normal position, and the epoxy sealing the coil was broken.

Event Description

It was reported that symptomatic patient experiencing muscle stimulation presented in clinic.The pulse generator could not be interrogated, multiple programmers were used unsuccessfully.The pulse generator was explanted and replaced on (b)(6) 2014.

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: jennie hamel ; 15900 valley view court; sylmar, CA 91342 ; 8184933462
• MDR Report Key: 4073866
• MDR Text Key: 4923466
• Report Number: 2017865-2014-16845
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2013
• Device Model Number: PM2210
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2012
• 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 Outcome(s): Required Intervention
• Patient Age: 34 YR