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

Model Number CDVRA500Q

Device Problem Under-Sensing (1661)

Patient Problems Dyspnea (1816); Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2023

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic for follow-up.Upon interrogation, it was found that the implantable cardioverter defibrillator (icd) exhibited under-sensing.No intervention was performed.Patient condition was stable.

Event Description

New information noted that the device was explanted and replaced on (b)(6) 2023.No adverse patient consequences were reported.

Event Description

New information noted that the device was explanted.The patient reported shortness of breath and discomfort.No further patient consequences were reported.

Manufacturer Narrative

Fild should reflect additional symptoms of discomfort and shortness of breath which was not mentioned in prior report.

Manufacturer Narrative

The reported event of undersensing was confirmed.The device image was analyzed by tech services and undersensing due to programmed settings was confirmed.The device behaved as programmed.Telemetry, impedance, sensing, pacing and high voltage (hv) output functions of the device were tested and found to be normal.

• 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: 17665386
• MDR Text Key: 322441261
• Report Number: 2017865-2023-40786
• 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,Followup,Followup
• Report Date: 12/06/2023

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: A000143015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 09/15/2023; 10/17/2023; 11/10/2023
• Supplement Dates FDA Received: 10/04/2023; 10/17/2023; 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2023
• 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: OPTISURE MRI.
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male