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

Model Number	PM2136
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hematoma (1884); Unspecified Infection (1930); Pocket Erosion (2013)
Date of Event	12/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sterilization records were reviewed and no evidence of abnormal sterilization cycle was found.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that the patient presented with hematoma, drainage, redness and swelling at the pacemaker implant site, consistent with an infection.The physician elected to explant the pacemaker on (b)(6) 2026.The patient remained in stable condition throughout the procedure.
Additional Manufacturer Narrative
Correction, section b3, d6b and h6: the correct event date is (b)(6) 2025, the explant date is (b)(6) 2025, and the component code should be 4755-part/component/sub-assembly term not applicable.
Event or Problem Description
New information received notes that the patient presented on (b)(6) 2025 with a pocket rupture secondary to infection.In response, the physician elected to perform complete explantation of the pacing system, including the pacemaker, the right atrial (ra) and right ventricular (rv) leads, which was carried out on (b)(6) 2025.
Event or Problem Description
New information received indicated that when the patient presented to the clinic with an unspecified infection, the physician noted that some functions of the pacemaker were disabled and that the device was not in a fully operational state.

• Brand Name: SUSTAIN XL DR
• 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: 24320116
• Report Number: 2017865-2026-02987
• Device Sequence Number: 9541894
• Product Code: NVZ
• UDI-Device Identifier: 05414734504713
• UDI-Public: (01)05414734504713(10)P000133285(17)230430
• 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: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2026

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: PM2136
• Device Lot Number: P000133285
• Was Device Available for Evaluation?: No
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 04/08/2026; 04/15/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/28/2026; 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2021
• 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