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

Model Number	PM1210
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Sense (1559); Low impedance (2285); Capturing Problem (2891)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient's pacemaker presented with abnormal battery consumption.An examination in clinic found the low pacing impedance.Loss of sensing, and high capture thresholds.The pacemaker was explanted and replaced on (b)(6)2024.Post-procedure the patient was stable.
Additional Manufacturer Narrative
The reported event of premature discharge of battery and low pacing impedance was not confirmed.The device was received with normal lead impedance and normal output.Visual inspection was performed to assess the header and its connectors, which determined to be normal.Signs of dent and scratches was noted on the metal housing.Electrical and mechanical tests performed including lead impedance and outputs verification did not identify any functional issues.Longevity assessment found the device was operating at normal voltage range, with appropriate remaining longevity.

• 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: 20811134
• Report Number: 2017865-2024-71273
• Device Sequence Number: 9934755
• Product Code: NVZ
• UDI-Device Identifier: 05414734502757
• UDI-Public: (01)05414734502757(10)S000065798(17)200430
• 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: 2020
• 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
• Report Date (Section B): 01/30/2025

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: 04/30/2020
• Device Model Number: PM1210
• Device Lot Number: S000065798
• 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: 11/10/2024
• Supplement Date Received by Manufacturer: 01/18/2025
• Initial Report FDA Received Date: 11/29/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown