MAUDE Adverse Event Report: ABBOTT SUSTAIN XL SR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number	PM1136
Medical Device Problem Codes	Failure to Interrogate (1332); Pacemaker Found in Back-Up Mode (1440); Unexpected Mode Switch (4076)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device was in backup mode and unable to be interrogated via inductive telemetry during an in clinic follow-up.The device was explanted and replaced to resolve the event and the patient was in stable condition.
Additional Manufacturer Narrative
The reported event of backup mode was confirmed and the event of failure to interrogate was not confirmed.The device was received with normal telemetry communication and the output was set to the backup mode rate.Analysis of the device image indicated device was operating in backup mode at above elective replacement indicator (eri) voltage level.Data corruption was also detected.The device was cut open to enable further testing and the battery was found at end-of-service levels.The device was recovered from backup mode with an external power source to perform further evaluation.Electrical and mechanical tests indicated normal device functionality.Despite extensive efforts, the backup mode could not be reproduced in the lab.There were no device anomalies found that could contribute to the reported events.

• Brand Name: SUSTAIN XL SR
• Common Device Name: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18457537
• Report Number: 2017865-2024-00535
• Device Sequence Number: 15240083
• Product Code: NVZ
• UDI-Device Identifier: 05414734504737
• UDI-Public: 05414734504737
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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: 06/30/2014
• Device Model Number: PM1136
• Device Lot Number: 3879395
• 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: 12/22/2023
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2012
• 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