BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TVL ADX

    MDR report key: 3872989 · Received June 13, 2014

    Report

    Report Number
    2938836-2014-11821
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    April 16, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOSS OF SENSING AND INTERMITTENT UNDERSENSING AND OVERSENSING WERE OBSERVED. LEAD WAS CAPPED. PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350069 TVL ADX DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1559/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention