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

Model Number	PM2134
Medical Device Problem Code	Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented for a follow up visit in the clinic.Upon interrogation, it was noted that the pacemaker was found in back-up vvi mode.Programming changes were made but it was unsuccessful.The pacemaker was explanted and replaced.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of backup operation was confirmed.Analysis of device image found the device went into backup mode due to non maskable interrupt (nmi).After the device was restored from backup mode, functional testing was performed.Further analysis performed did not find any anomaly.Longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.The backup operation could not be reproduced.The cause of the reported event could not be determined.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18449832
• Report Number: 2017865-2024-00479
• Device Sequence Number: 7660324
• Product Code: NVZ
• UDI-Device Identifier: 05414734504720
• UDI-Public: 05414734504720
• 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: 2024
• 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): 03/12/2024

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: 02/28/2023
• Device Model Number: PM2134
• Device Lot Number: P000130705
• 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: 12/28/2023
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• 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