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

Model Number	PM1136
Medical Device Problem Code	Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a pacemaker upgrade procedure, the patient had a rapid ventricular tachycardia episode.The episode was terminated by external defibrillation.Following the external defibrillation the pacemaker was observed to be in backup mode.The event was resolved by explanting and replacing the pacemaker during the upgrade procedure.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of backup operation was confirmed.Device was received in backup mode which was triggered during the explant procedure consistent with exposing the device to external defibrillation.After re-loading the product code successfully, the device was tested under electrical and mechanical conditions and test results indicated the device exhibited normal functionality with battery voltage above elective replacement level.Longevity assessment was performed, and the device was 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
• MDR Report Key: 11562431
• Report Number: 2017865-2021-12629
• Device Sequence Number: 14498911
• 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 Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

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: 10/31/2015
• Device Model Number: PM1136
• Device Catalogue Number: PM1136
• Device Lot Number: 4556834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1