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

Model Number	PM2134
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332)
Health Effect - Clinical Codes	Arrhythmia (1721); Dizziness (2194); Syncope/Fainting (4411)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented in clinic due to symptoms of low heart rate, dizziness.And fainting.The patient's pacemaker failed to be interrogated, and it was believed that the battery had depleted prematurely.The pacemaker was explanted and replaced.Patient was stable.
Additional Manufacturer Narrative
The reported event of premature discharge of battery and no magnet response was confirmed.The device was received with no telemetry communication and no output.The device was cut open to enable further testing and the battery was found depleted.Destructive analysis of the battery cell found no defects.The hybrid circuitry was tested and results indicated normal current drain.Electrical and mechanical tests, including telemetry communication and output verification, did not identify any functional issues.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.The abnormal battery depletion was caused by an integrated circuit anomaly within the hybrid.

• Brand Name: SUSTAIN XL DC
• 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: 21853660
• Report Number: 2017865-2025-40282
• Device Sequence Number: 21007454
• Product Code: NVZ
• UDI-Device Identifier: 05414734504720
• UDI-Public: (01)05414734504720(10)P000092296(17)210430
• 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: 2020
• 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
• Report Date (Section B): 07/28/2025

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: 04/30/2021
• Device Model Number: PM2134
• Device Lot Number: P000092296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2019
• 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