MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT VR; NO MATCH

Model Number CDVRA500Q

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 02/12/2024

Event Type  Injury  

Event Description

It was reported that the patient stated the implantable cardioverter defibrillator moved and made a popping sound.Further information was requested however, was not provided.

Event Description

The patients device was explanted and replaced on (b)(6) 2024.The patient was in stable condition.

Manufacturer Narrative

The device was returned and analyzed in lab.Interrogation of the device revealed the device was above elective replacement indicator (eri).Telemetry, pacing, sensing, impedance, hv output, hv shock, capacitor maintenance, and patient notifier were tested on the bench.No anomaly was detected.

• Brand Name: GALLANT VR
• Type of Device: NO MATCH
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18833973
• MDR Text Key: 336917756
• Report Number: 2017865-2024-34069
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067031990
• UDI-Public: 05415067031990
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

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
• Device Operator: Health Professional
• Device Model Number: CDVRA500Q
• Device Lot Number: A000149146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DURATA
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male