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

Model Number	PM1136
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332); Data Problem (3196); No Pacing (3268)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced dizziness.An error message was displayed and the device could not be interrogated.Abbott technical support was contacted and it was suspected that the device had reached end of service (eos).Premature battery depletion was suspected.The device was explanted and replaced to resolve the event.The patient was in stable condition.Additional information was requested but was not available.
Additional Manufacturer Narrative
The reported field event of premature battery depletion, failure to interrogate, data problem and loss of pacing were not confirmed.The device was received in backup operation.The device image showed code corruption and this was the cause of the backup operation.Analysis performed after reloading product code indicated normal device characteristics, voltage is still above elective replacement indicator (eri) level.Device was able to interrogate, and no anomaly was noted on pacing.Code corruption could not be reproduced.The device longevity assessment was performed and the device was found to be in the normal range of operation with appropriate remaining longevity.

• Brand Name: SUSTAIN XL SR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 14504521
• Report Number: 2017865-2022-11015
• Device Sequence Number: 5106837
• Product Code: NVZ
• UDI-Device Identifier: 05414734504737
• UDI-Public: 05414734504737
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• 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): 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: PM1136
• Device Catalogue Number: PM1136
• Device Lot Number: 4119032
• 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: 05/10/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2013
• 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
• Patient Sex: Unknown