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

Model Number PM1210

Device Problems Pacing Problem (1439); Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Discomfort (2330)

Event Date 02/07/2024

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 336325227
• Report Number: 2017865-2024-33480
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734502757
• UDI-Public: 05414734502757
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/07/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male