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

Model Number	5610
Medical Device Problem Code	Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During a clinic follow up, it was noted that the device went into back up mode.The device was explanted and exchanged to resolve the event and the patient was stable following the procedure.
Additional Manufacturer Narrative
Analysis of the device image obtained from the pacemaker noted the device was in bvvi mode.The battery voltage and current trends were normal.Functional testing after reloading the product code resulted in normal device characteristics.The reported event of backup vvi mode was confirmed; however, the cause of the reset could not be determined from the device analysis in the laboratory setting.

• Brand Name: VICTORY XL SR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 7852122
• Report Number: 2017865-2018-13314
• Device Sequence Number: 13872883
• Product Code: LWP
• UDI-Device Identifier: 05414734009539
• UDI-Public: 05414734009539
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

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: 12/31/2010
• Device Model Number: 5610
• Device Lot Number: 2911185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 10/19/2018
• 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