BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA MP

    MDR report key: 10336198 · Received July 28, 2020

    Report

    Report Number
    2017865-2020-10028
    Event Type
    Injury
    Date Received
    July 28, 2020
    Date of Event
    July 10, 2020
    Report Date
    July 28, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NIK
    UDI-DI
    05414734508377
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR REMOTE FOLLOW UP VIA MERLIN. NET WITH EXHIBITING AN ALERT FOR SHORTED OUTPUT STAGE DETECTION. THERE WAS RECORDED EPISODES OF NOISE RESULTING IN INAPPROPRIATE THERAPY. THE PATIENT SUBSEQUENTLY PRESENTED FOR IN-CLINIC DEVICE INTERROGATION. IT WAS REVEALED THAT THE SOURCE OF NOISE WAS ELECTROCAUTERY USED DURING AN UNRELATED SURGICAL PROCEDURE, DURING WHICH THE HEALTH PROVIDER HAD NOT DEACTIVATED DEFIBRILLATION THERAPY. THE PATIENT HAD BEEN SEDATED DURING THE PROCEDURE AND WAS UNAWARE OF ANY THERAPY DELIVERED. THE CAPACITOR WAS FOUND TO BE FUNCTIONING PROPERLY. THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796051 QUADRA ASSURA MP IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CD3369-40Q A000059943 05414734508377

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other