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

Model Number	5610
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
During a follow-up, it was noted that the battery was significantly depleted.The device is anticipated to be explanted and replaced to resolve the event.The patient experienced no adverse consequences.
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
Additional information indicated the device was explanted and replaced to resolve the event.The patient was in stable condition following the procedure.

• Brand Name: VICTORY XL SR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10804656
• Report Number: 2017865-2020-16864
• Device Sequence Number: 3931473
• Product Code: LWP
• UDI-Device Identifier: 05414734009539
• UDI-Public: 05414734009539
• 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: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

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: 07/31/2012
• Device Model Number: 5610
• Device Catalogue Number: 5610
• Device Lot Number: 3310895
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 11/26/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention