BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 3923410 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14693
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 3, 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 Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND LEAD DAMAGE CONSISTENT WITH CLAVICULAR CRUSH. INSULATION DAMAGE WAS NOTED AT 22.0CM FROM THE CONNECTOR PIN. A SHORT CIRCUIT WAS ALSO NOTED AT THE SAME LOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVERSENSING ON THE ATRIAL LEAD HAD RESULTED IN AN INHIBITION OF THERAPY. LOW IMPEDANCE WAS ALSO NOTED AND THE PHYSICIAN SUSPECTED THAT THE LEADS INSULATION HAD BEEN DAMAGED. IT WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399787 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)