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

Model Number	PM2110
Medical Device Problem Codes	No Pacing (3268); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an auditory alert demonstrated and presented to the clinic.Upon review the pacemaker, it was no alert presented.No intervention was performed.The patient was stable and would be further monitored.
Event or Problem Description
Additional information received notes that the pacemaker was explanted and replaced on (b)(6) 2024.
Event or Problem Description
Additional information received notes that the pacemaker was explanted due to non-responsiveness.The patient remained in stable condition.
Additional Manufacturer Narrative
The reported events of no pacing and noise audible could not be confirmed.The pacer was received in normal working conditions with battery voltage at elective replacement indicator (eri).Cautery marks were noted on pacer consistent with inhibited pacing during explant.Electrical and mechanical analysis performed, including output verification, indicated normal device functionality.When automatic settings are programed, the device output would adjust itself to accommodate the patient¿s needs for pacing and thus affect the estimated longevity of the device.The implant duration exceeds the projected longevity based on average monthly current indicating normal battery depletion.

• Brand Name: ACCENT DR
• 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: 18451872
• Report Number: 2017865-2024-00477
• Device Sequence Number: 7633056
• Product Code: NVZ
• UDI-Device Identifier: 05414734503600
• UDI-Public: 05414734503600
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/03/2025

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: 04/30/2015
• Device Model Number: PM2110
• Device Lot Number: 4275439
• 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: 12/29/2023
• Supplement Date Received by Manufacturer: 01/07/2025; 01/23/2025; 03/31/2025
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 01/22/2025; 02/09/2025; 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2013
• 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: RIGHT ATRIAL LEAD; TENDRIL LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female