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

Model Number PM2210

Device Problems Premature Discharge of Battery (1057); Incorrect Measurement (1383); Pacing Intermittently (1443)

Patient Problem Dizziness (2194)

Event Date 10/29/2021

Event Type  Injury  

Event Description

It was reported that a patient presented in clinic for follow up.Upon interrogation, the pacemaker was pacing intermittently.Additionally, the device stated that the battery reached elective replacement indicator on (b)(6) 2021, but on (b)(6) 2021 the battery voltage was below end-of-life level, indicating a device diagnostic issue.The patient felt dizzy during the interrogation.The pacemaker was explanted and replaced.The patient was in stable condition post-procedure.

Manufacturer Narrative

The reported event of pacing intermittently was confirmed while the event of incorrect measurement was not confirmed.Interrogation of the device revealed it was at end of life.The intermittent pacing was due to the battery voltage being very low.Device image analysis revealed the previous elective replacement indicator had been overwritten when the voltage dropped below the threshold set on the device.Longevity analysis showed normal battery depletion.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12824558
• MDR Text Key: 280879525
• Report Number: 2017865-2021-36599
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734503617
• UDI-Public: 05414734503617
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880086
• 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
• Report Date: 12/28/2021

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: 03/31/2012
• Device Model Number: PM2210
• Device Catalogue Number: PM2210
• Device Lot Number: 3222120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 12/08/2021
• Supplement Dates FDA Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2010
• 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
• Treatment: MERLIN PROGRAMMER; TENDRIL ST; TENDRIL ST
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female