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

Model Number	5810
Medical Device Problem Codes	Premature Discharge of Battery (1057); Failure to Interrogate (1332)
Health Effect - Clinical Codes	Bradycardia (1751); Fatigue (1849)
Date of Event	12/13/2018
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 patient presented in clinic for follow up.Upon review, premature battery depletion was suspected based off a previous longevity estimate.The patient has an underlying brady rhythm.No intervention was reported.
Additional Manufacturer Narrative
The previously reported device manufacture date of jan 11, 2010 was incorrect.The correct information is jan 12, 2010.
Event or Problem Description
New information received noted the patient presented for a pacemaker explant and replacement procedure.The day of the procedure, the device was unable to be interrogated.Complete battery depletion was suspected.The patient experienced bradycardia and reported feeling fatigued for the weeks prior.The device was explanted and replaced on (b)(6) 2019.The patient was stable throughout.

• 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: 8171735
• Report Number: 2017865-2018-19046
• Device Sequence Number: 13804562
• Product Code: LWP
• UDI-Device Identifier: 05414734009546
• UDI-Public: 05414734009546
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P880086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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: 07/31/2011
• Device Model Number: 5810
• Device Lot Number: 2931372
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 03/19/2019
• 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