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

Model Number	5610
Medical Device Problem Codes	Intermittent Capture (1080); Pacemaker Found in Back-Up Mode (1440)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
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 patient presented for a routine generator change procedure.During exposure to electrocautery, the pulse generator reverted to backup operation.Intermittent loss of capture was noted due to the change to unipolar pacing.Further interrogation was not possible due to the device's backup operation.The device was removed and replaced.The patient was stable.
Additional Manufacturer Narrative
The reported event of backup mode was confirmed.Analysis of the device indicated that the backup mode was triggered as a result of low voltage fluctuations consistent with electrocautery exposure.

• Brand Name: VICTORY XL SR
• 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: 7733367
• Report Number: 2017865-2018-11111
• Device Sequence Number: 1618268
• Product Code: LWP
• UDI-Device Identifier: 05414734009539
• UDI-Public: 05414734009539
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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: 07/31/2011
• Device Model Number: 5610
• Device Lot Number: 3061807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1