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

Model Number	5810
Medical Device Problem Codes	Difficult to Interrogate (1331); Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Codes	Muscle Stimulation (1412); Discomfort (2330)
Date of Event	03/20/2019
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
It was reported that the device exhibited backup vvi operation most probably due to low battery.Due to poor telemetry the device was not restored from backup to normal functions.The patient experienced pocket stimulation and discomfort.No intervention was performed.The patient will continue to be monitored.
Event or Problem Description
New information states that device replacement was discussed.The patient was in a stable condition.

• 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: 8485568
• Report Number: 2017865-2019-05025
• Device Sequence Number: 1538122
• Product Code: LWP
• UDI-Device Identifier: 05414734009546
• UDI-Public: 05414734009546
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2011
• Device Model Number: 5810
• Device Lot Number: 2831333
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 60