MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ACCENT DR RF PACEMAKER; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM2210

Device Problems Difficult to Interrogate (1331); Pacemaker Found in Back-Up Mode (1440); Premature End-of-Life Indicator (1480); Premature Elective Replacement Indicator (1483); Loss of Data (2903)

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

Event Date 09/19/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that following possible external defibrillation, the pulse generator exhibited a diagnostics anomaly.Troubleshooting was attempted but unsuccessful.It was noted that there was difficulty establishing communication with the device due to local sources of electromagnetic interference.Successful interrogation was achieved and the device was found to be operating in backup vvi mode.The patient was noted to be in stable condition.No intervention was reported.

Event Description

New information reported that the device was successfully explanted and replaced on (b)(6) 2015.

• Brand Name: ACCENT DR RF PACEMAKER
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 15900 valley view court; sylmar, CA 91342 ; 8184934022
• MDR Report Key: 5264964
• MDR Text Key: 32664463
• Report Number: 2017865-2015-30660
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2012
• Device Model Number: PM2210
• Device Lot Number: 3350545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/17/2011
• 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
• Patient Age: 81 YR