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

Model Number	5810
Medical Device Problem Codes	Failure to Interrogate (1332); Battery Problem (2885)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During follow-up, the physician was unable to interrogate the device.Technical support was contacted but premature battery depletion could not be confirmed.The device was explanted and replaced to resolve the issue.The patient was in stable condition.
Event or Problem Description
New information was received that the correct serial number for the device was (b)(4).
Additional Manufacturer Narrative
The reported event of early battery depletion was not confirmed.The device was received without telemetry, and battery having reached end of life (eol) after exceeding projected longevity.The device image could not be saved due to battery condition and a request was made to the field, but the device image was not available.After cutting open the device and replacing the battery, the device was tested under nominal conditions with normal results.Additionally, the pacer was programmed and tested under three different pulse amplitude levels and the results indicate the drain current was within normal range.

• Brand Name: VICTORY XL DR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8569477
• Report Number: 2017865-2019-06229
• Device Sequence Number: 1731397
• Product Code: LWP
• UDI-Device Identifier: 05414734009546
• UDI-Public: 05414734009546
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2019

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: No Information
• Device Expiration Date: 08/31/2013
• Device Model Number: 5810
• Device Lot Number: 3622141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 05/22/2019; 07/25/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 05/23/2019; 07/26/2019
• 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: Hospitalization; Required Intervention
• Patient Weight: 80