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

Model Number	PM1210
Medical Device Problem Codes	Failure to Interrogate (1332); Pacing Problem (1439)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for a follow-up in clinic with a declined ventricular rate.It was noted that the pacemaker had no magnet response.The pacemaker was explanted and replaced.The patient was stable.
Event or Problem Description
It was reported that the pacemaker failed to be interrogated and exhibited an unspecified low voltage output issue.
Additional Manufacturer Narrative
The reported events of pacing output issue, no magnet response, and inability to interrogate were confirmed.The device was received with no output and no telemetry communication.The device was cut open for further testing and the battery was found depleted.The device was tested by connecting to an external power source.Test results indicated elevated current drain, isolated to a defective component on the flex rf module, depleting the battery sooner than expected.

• Brand Name: ACCENT SR RF
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 20356981
• Report Number: 2017865-2024-66384
• Device Sequence Number: 7199248
• Product Code: NVZ
• UDI-Device Identifier: 05414734502757
• UDI-Public: (01)05414734502757(10)S000079512(17)220430
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: PM1210
• Device Lot Number: S000079512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 09/18/2024; 11/15/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/15/2024; 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROGRAMMER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown