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

Model Number	PM1134
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Unexpected Mode Switch (4076)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	12/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the hospital after experiencing inappropriate stimulation in the pocket area.Upon interrogation, the pacemaker was found in backup mode.The pacemaker was explanted and replaced.The patient was stable.
Additional Manufacturer Narrative
Device evaluation : the reported event of unexpected mode switch and muscle stimulation were confirmed.The device was received in backup mode with normal telemetry communication.Device was at unipolar pacing at backup mode.Analysis of the device image indicated non-maskable interrupt (nmi) had occurred and reverted device to backup operation, this is consistent with electromagnetic interference during the gastric surgery.After the product code was reloaded, the device exhibits normal characteristics.Electrical tests performed did not identify any functional issues.Longevity assessment was performed and the device was in normal range of operation with appropriate remaining longevity.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.Correction section d6a - date of implant: updated from "(b)(6) 2021" to (b)(6) 2021" based on analysis.

• Brand Name: SUSTAIN XL SC
• 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: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 24082656
• Report Number: 2017865-2026-00968
• Device Sequence Number: 18566065
• Product Code: NVZ
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/24/2026

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: 02/28/2022
• Device Model Number: PM1134
• Device Lot Number: P000109085
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 01/18/2026; 04/01/2026; 06/04/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 01/26/2026; 04/01/2026; 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2020
• 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 Sex: Unknown