BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT DR RF

    MDR report key: 3900997 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12682
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    March 18, 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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW-UP, AN EGM SHOWED THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY. THE THERAPY OCCURRED DUE TO EXPOSURE TO EMI DURING AN UNRELATED PROCEDURE. THE DEVICE REMAINS IMPLANTED. THERE HAVE BEEN NO FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380010 CURRENT DR RF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD 2207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR (B)(4)