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 Interrogate (1332)
Health Effect - Clinical Codes	Arrhythmia (1721); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pacing dependent patient presented for routine in-clinic follow up.During the follow up the pulse generator was unable to be interrogated.Sudden premature battery depletion was suspected.The patient was scheduled for explant and the device was replaced.The patient was stable.
Additional Manufacturer Narrative
Reported event of premature discharge of battery and failure to interrogate were not confirmed.The device voltage was above elective replacement indicator (eri) level upon receipt.Analysis of device image and session records indicated autocapture and rate responsive feature were enabled during implant period.When automatic settings are programmed, such as autocapture and rate responsive feature, the device would adjust itself to accommodate the patient¿s needs for pacing and thus affects the estimated longevity of the device.Longevity assessment was performed, and implant duration exceeded total projected longevity indicating normal battery depletion.Further analysis performed found no anomaly, the device was able to be interrogated successfully throughout analysis.

• 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: 18691102
• Report Number: 2017865-2024-22408
• Device Sequence Number: 18272279
• Product Code: NVZ
• UDI-Device Identifier: 05414734502757
• UDI-Public: 05414734502757
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/19/2024

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: 07/31/2013
• Device Model Number: PM1210
• Device Lot Number: 3602265
• 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: 01/24/2024
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TENDRIL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male