MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) GALLANT VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CDVRA500Q

Device Problems Failure to Interrogate (1332); Wireless Communication Problem (3283)

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

Event Date 03/08/2023

Event Type  malfunction  

Manufacturer Narrative

Further information was requested, but not received.

Event Description

It was reported that a patient presented in a non-clinical environment with loss of bluetooth low energy telemetry noted on the patient¿s implantable cardioverter defibrillator.No intervention or adverse patient consequences were reported.

Manufacturer Narrative

The reported event of an inability to communicate via remote monitoring was confirmed.The issue was resolved by bring the patient into clinic for device interrogation.No further investigation is required at this time.The results of the software analysis are inconclusive since no additional information was obtained to investigate.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

New information received notes that the device was interrogated and the interrogation successfully restored the device, indicating a bluetooth low energy telemetry lockout.No further patient consequences were reported.

• Brand Name: GALLANT VR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 16660410
• MDR Text Key: 312495208
• Report Number: 2017865-2023-16386
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CDVRA500Q
• Device Catalogue Number: CDVRA500Q
• Device Lot Number: P000150863
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2022
• 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 TACHY.
• Patient Age: 69 YR
• Patient Sex: Male