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

Model Number	PM1136
Medical Device Problem Code	No Pacing (3268)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a routine device exchange, there was a loss of cardiac pacing while using a plasma blade diathermy which resulted in the patient experiencing asystole.The arrhythmia was terminated using external pacing.The patient was stable.
Additional Manufacturer Narrative
As received, the device was above elective replacement indicator and electrocautery marks were noted on the device.The user manual indicated that electrosurgical cautery could inhibit the pulse generator operation.The device was then programed to nominal settings for the remainder of the analysis.The results of all electrical test performed, including mechanical stress testing and battery assessment indicate normal device characteristics.Longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.The event of a loss of low voltage output was not confirmed.

• 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: 12862570
• Report Number: 2017865-2021-37457
• Device Sequence Number: 14526158
• 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: 2012
• Device Explanted Year: 2021
• 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): 03/15/2022

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: 04/30/2013
• Device Model Number: PM1136
• Device Catalogue Number: PM1136
• Device Lot Number: 3525108
• Was Device Available for Evaluation?: No
• 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: 11/18/2021
• Supplement Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2011
• 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