MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) VICTORY XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number	5810
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	02/28/2019
Type of Reportable Event	Serious Injury
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
It was reported that the pulse generator exhibited backup vvi mode.Upon interrogation, the device exhibited elective replacement indicator ¿ eri.It was noted the patient was lost to follow-up.No intervention was reported.The patient was in stable condition.
Event or Problem Description
New information received noted that the device was explanted and replaced on (b)(6) 2019.The patient tolerated the procedure well and was in stable condition.
Additional Manufacturer Narrative
The reported event of backup mode was confirmed and was consistent with normal battery depletion.Device was in backup mode when received.Analysis of the device image indicated the device being implanted beyond its projected longevity period and went into backup mode, consistent with low battery voltage.Device was implanted for 9.86 years, which exceeded the projected longevity and is considered normal battery depletion.

• Brand Name: VICTORY XL DR
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8423559
• Report Number: 2017865-2019-03881
• Device Sequence Number: 2242226
• Product Code: LWP
• UDI-Device Identifier: 05414734009546
• UDI-Public: 05414734009546
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2019

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: Health Professional
• Device Expiration Date: 09/30/2010
• Device Model Number: 5810
• Device Lot Number: 2780775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 05/09/2019; 05/30/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 05/22/2019; 06/02/2019
• 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: Required Intervention