BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT RF VR

    MDR report key: 3854602 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11603
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 17, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC AFTER RECEIVING INAPPROPRIATE ATP AND HIGH VOLTAGE THERAPY FOR AN SUPRAVENTRICULAR TACHYCARDIA WITH RAPID VENTRICULAR RESPONSE. THE PATIENT WAS ASYMPTOMATIC. THE DEVICE WAS REPROGRAMMED AND REMAINS IMPLANTED. NO SUBSEQUENT EVENTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332053 CURRENT RF VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 1207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention