BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 3926029 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15417
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    May 20, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THE ATRIAL LEAD HAD CAUSED A BULGE UNDER THE SKIN. LEAD REVISION SHOWED THAT THE LEAD HAD DISLODGED THROUGH PATIENT MANIPULATION, OR TWIDDLING. THE LEAD WAS REPOSITIONED AND THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403234 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 2088TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4)