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

Model Number	PM1110
Medical Device Problem Codes	Incorrect Measurement (1383); Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for a follow-up visit at the clinic.Upon interrogation, it was noted that the pacemaker exhibited a backup vvi mode.Programming changes were made.The rate adaptive pacing (rap) was lower than expected after restoration.The patient was stable.
Additional Manufacturer Narrative
The reported event was unable to be verified due to lack of device image or session record following the firmware restoration.The root cause of the event cannot be determined as no session record or device image was available.

• Brand Name: ACCENT SR
• 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 21862624
• Report Number: 2017865-2025-40476
• Device Sequence Number: 15428300
• Product Code: NVZ
• UDI-Device Identifier: 05414734502740
• UDI-Public: (01)05414734502740(10)S000073343(17)210430
• 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
• 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): 05/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: PM1110
• Device Lot Number: S000073343
• Was Device Available for Evaluation?: No
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2019
• 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: TENDRIL LEAD
• Patient Sex: Unknown