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

Model Number	PM2134
Medical Device Problem Codes	Incorrect Measurement (1383); No Pacing (3268)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	06/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient fainted and was subsequently admitted to the hospital.Upon interrogation, it was found that the patient's pacemaker failed to deliver low voltage output.It was further noted that an overestimation of battery longevity was provided by the device.The device was explanted and replaced.The patient was stable.
Additional Manufacturer Narrative
The reported events of no pacing, and incorrect measurement were not confirmed.Final analysis via device image indicated auto-capture was enabled.When automatic settings are programmed, such as auto-capture, the device output would adjust itself to accommodate the patient¿s needs for pacing and thus affect the estimated longevity of the device.No anomalies were detected.
Additional Manufacturer Narrative
The reported events of no pacing, and incorrect measurement were not confirmed.Final analysis found the device was above elective replacement indicator (eri) battery voltage upon receipt and eri alert was falsely triggered during analysis due to the device having been exposed to cold temperature.Review of the device image indicates auto-capture was enabled.When automatic settings are programmed, such as auto-capture, the device output would adjust itself to accommodate the patient¿s needs for pacing and thus affect the estimated longevity of the device.Electrical and mechanical analysis performed indicated normal functionality with normal measurements.No anomalies were detected.

• 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: 19752214
• Report Number: 2017865-2024-60321
• Device Sequence Number: 8874906
• Product Code: NVZ
• UDI-Device Identifier: 05414734504720
• UDI-Public: (01)05414734504720(10)4529886(17)150930
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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,Followup
• Report Date (Section B): 11/20/2024

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: 09/30/2015
• Device Model Number: PM2134
• Device Lot Number: 4529886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2024
• 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: 06/27/2024
• Supplement Date Received by Manufacturer: 08/09/2024; 11/11/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/28/2024; 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2014
• 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