MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. VICTORY XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5810
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During a follow-up in clinic, the device was interrogated and an estimation of remaining longevity could not be obtained.A message was then delivered indicating the device had reached elective replacement indicator (eri).The device was explanted and replaced and the patient was stable with no consequences.
Additional Manufacturer Narrative
Upon receipt, the device was interrogated with a programmer and communication was established.The device image was obtained and analyzed, indicating the average monthly voltage and current trends were normal.A false elective replacement indicator (eri) alert was noted due to autocapture being programmed on and the device functioning in high output mode (hom).The remaining longevity was not displayed due to the eri alert being triggered.Vibration testing, device output testing, and pacing rate testing was performed and no anomalies were noted.Stress tests were performed and did not find any high current anomalies.Longevity assessment was performed and the device was in normal range of operation with appropriate remaining longevity.The reported events of the remaining longevity being unobtainable and an eri alert were confirmed.

• Brand Name: VICTORY XL DR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 7703791
• Report Number: 2017865-2018-10582
• Device Sequence Number: 805323
• Product Code: LWP
• UDI-Device Identifier: 05414734009546
• UDI-Public: 05414734009546
• 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
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018

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: 06/30/2012
• Device Model Number: 5810
• Device Lot Number: 3267946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 08/16/2018
• 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