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

Model Number	PM2110
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in clinic for follow up.Upon interrogation, it was noted that the pacemaker was over-sensing noise.No changes or intervention was reported.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of over-sensing was not confirmed.The device was received from the field with battery voltage at elective replacement indicator (eri) level.Visual inspection of the header noticed the setscrews stripped by the end-user caused by inserting the wrench tool at angles to the inset.No contamination or foreign material noted.Electrical analysis performed, after replacing the setscrews, indicated normal functionality.Further sensitivity test performed at most sensitive level measured normal sensing parameters.Longevity assessment was performed based on field settings and the device exceeded projected longevity indicating normal battery depletion.
Event or Problem Description
New information noted that the pacemaker was explanted and replaced.

• 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: 17705828
• Report Number: 2017865-2023-42386
• Device Sequence Number: 7165508
• Product Code: NVZ
• UDI-Device Identifier: 05414734503600
• UDI-Public: 05414734503600
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2024

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: 09/30/2013
• Device Model Number: PM2110
• Device Lot Number: 3659059
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2012
• 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 Age: 54 YR
• Patient Sex: Male