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

Model Number	PM2210
Medical Device Problem Codes	High impedance (1291); Capturing Problem (2891)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the hospital for a scheduled procedure.The patient's pacemaker exhibited high capture threshold and high impedance measurement.The pacemaker was explanted and replaced.The patient was discharged with no reports of adverse consequences.
Additional Manufacturer Narrative
The reported events of capture problem, and high impedance were not confirmed.The device was at elective replacement indicator (eri) level upon receipt.Electrical and mechanical analysis performed indicated normal functionality.Further evaluation of capture performance found normal capture results, and output signal verification confirmed all parameters were within normal range.Longevity assessment was performed, based on average drain current, and the device exceeded projected longevity indicating normal battery depletion.

• Brand Name: ACCENT DR RF PACEMAKER
• 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: 20661304
• Report Number: 2017865-2024-69532
• Device Sequence Number: 7305008
• Product Code: NVZ
• UDI-Device Identifier: 05414734503617
• UDI-Public: (01)05414734503617(10)4486264(17)150831
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

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: 08/31/2015
• Device Model Number: PM2210
• Device Lot Number: 4486264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2024
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2014
• 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 TENDRIL LEAD; RIGHT VENTRICULAR TENDRIL LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female