BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVL ADX

    MDR report key: 3288316 · Received August 14, 2013

    Report

    Report Number
    2938836-2013-04787
    Event Type
    Injury
    Date Received
    August 14, 2013
    Date of Event
    June 5, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT STATED THEY HAD BEEN DOING SOME HEAVY DUTY AXE AND CHAINSAW WORK. PATIENT WAS LYING IN BED THE NEXT DAY STRETCHING AND RECEIVED INAPPROPRIATE THERAPY DUE TO NOISE. THE NOISE WAS ABLE TO BE REPRODUCED. LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390675 TVL ADX DEFIBRILLATION LEAD LWS ST. JUDE MEDICAL, INC., CRMD 1559/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention