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

Model Number 5816

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2021

Event Type  malfunction  

Event Description

It was reported that during initial implant of a pacemaker, the physician was unable to insert a lead into the header of the device.The physician exchanged the pacemaker and the new device was successfully implanted.The patient was stable throughout.

Manufacturer Narrative

The reported field event of failure to connect leads to header was not confirmed in the laboratory.The device was tested on the bench and using automated testing equipment, and no anomalies were found.

• Brand Name: VICTORY XL DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11825392
• MDR Text Key: 250634444
• Report Number: 2017865-2021-18100
• Device Sequence Number: 1
• Product Code: DXY
• UDI-Device Identifier: 05414734009553
• UDI-Public: 05414734009553
• Combination Product (y/n): N
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 5816
• Device Catalogue Number: 5816
• Device Lot Number: P000099782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 08/06/2021
• Supplement Dates FDA Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1