MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) SUSTAIN XL SR; Pulse Generator, Permanent, Implantable

Model Number	PM1136
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented at clinic for a pacemaker replacement procedure due to pacing inhibition and loss of output.The patient experienced episodes of asystole.The pacemaker was explanted and successfully replaced.The patient remained stable throughout the procedure.
Additional Manufacturer Narrative
B5.
Event or Problem Description
It was reported that the patient presented at clinic for a standard pacemaker replacement procedure.During the procedure, cautery use resulted in inappropriate pacing inhibition and episodes of asystole.The pacemaker was explanted and successfully replaced.The patient remained stable.

• Brand Name: SUSTAIN XL SR
• 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: 24373759
• Report Number: 2017865-2026-03326
• Device Sequence Number: 17555176
• Product Code: NVZ
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/28/2026

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: 02/28/2015
• Device Model Number: PM1136
• Device Lot Number: 4213205
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/17/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 01/29/2026; 05/22/2026; 09/26/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 02/18/2026; 06/11/2026; 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2013
• 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 Sex: Unknown