BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALLANT VR

    MDR report key: 20029417 · Received August 22, 2024

    Report

    Report Number
    2017865-2024-62999
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 29, 2024
    Report Date
    October 30, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    UDI-DI
    05415067031990
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT #1 PI MAIN [PI-2024-0122177-01]. AN EVENT OF LOSS OF PAIRING RESULTING IN NO CLINICAL SIGNS, SYMPTOMS OR CONDITION WHICH CAUSED NO HEALTH CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED. THE STATUS OF APPLICATION IS NOT APPLICABLE AND IS NOT RETURNED. REMOTE CARE TECHNICAL SUPPORT WAS CONTACTED. ANALYSIS OF THE INFORMATION PROVIDED CONFIRMED THE EVENT OF LOSS OF PAIRING. A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT REQUIRED PER INVESTIGATION PROCEDURE. THE CAUSE OF THE EVENT WAS NOT DETERMINED. A CORRECTION WAS REQUESTED BY THE SOFTWARE ENGINEERING TEAM TO RESOLVE THE ISSUE IN THE FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR EXHIBITED LOSS OF BLUETOOTH TELEMETRY. NO INTERVENTION WAS PERFORMED. THERE WERE NO PATIENT CONSEQUENCES.

    Description of Event or Problem · 0

    NEW INFORMATION RECEIVED NOTES THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS IN BLUETOOTH TELEMETRY LOCKOUT. THE ISSUE WAS RESOLVED IN CLINIC VIA REINTERROGATION. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116623 GALLANT VR NO MATCH NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CDVRA500Q P000158589 05415067031990

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female DURATA