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

Model Number	PM1210
Medical Device Problem Codes	Pacing Problem (1439); Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented for a regular device change out.It was reported that after initial use of cauterization in the pocket of the device, pulsing in the pocket was observed.Once cauterization stopped, the pocket stimulation dissipated.This continued to occur as cauterization was used to open the pocket.Large pulse deflections were noted on electrocardiogram (ekg) with pocket stimulation appearing to indicate unipolar pacing.The device was interrogated again outside the pocket and settings were confirmed as at pre-op to be in bipolar configuration.Auto capture was programmed off and the polarity switched to monitor.No other issues were observed.The pacemaker was replaced successfully.The issue could not be reproduced with the replacement device.The physician commented on a possible zener diode function in relation to electromagnetic function post procedure.There were no patient consequences.
Additional Manufacturer Narrative
The reported events of pacing problem, and therapy delivered to incorrect body area were not confirmed.The device was received from the field with battery voltage above elective replacement indicator (eri) level, and electrocautery marks on the can.Electrical and mechanical analysis performed under nominal and field settings indicated normal functionality.Evaluation of the output signal at field conditions measured all pacing parameters within normal range.Additionally, visual inspection of the header and connector found no contamination or foreign material that could contribute to the reported events.Longevity assessment was performed, and the device was in normal rage of operation with appropriate remaining longevity.

• 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: 18784715
• Report Number: 2017865-2024-33480
• Device Sequence Number: 8332975
• Product Code: NVZ
• UDI-Device Identifier: 05414734502757
• UDI-Public: 05414734502757
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2014
• Device Model Number: PM1210
• Device Lot Number: 3746422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• 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: 02/07/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 02/26/2024
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2012
• 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
• Patient Age: 73 YR
• Patient Sex: Male