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

Model Number PM2210

Device Problems Difficult to Interrogate (1331); Device Operates Differently Than Expected (2913)

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

Event Date 01/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that an asymptomatic patient presented to the clinic during a follow-up.Slow telemetry and false messages that the device reached eos and the patient was seen couple months prior were noted.No other anomalies were noted.The patient was not exposed to emi or surgery.Reinstalling the fireware on the pacemaker was suggested.The issue was resolved.The patient was stable.

• Brand Name: ACCENT DR RF PACEMAKER
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6294394
• MDR Text Key: 66557992
• Report Number: 2938836-2017-13388
• 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
• Report Date: 01/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: PM2210
• Device Lot Number: 4396347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2013
• 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: 74 YR