BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 3926030 · Received July 10, 2014

    Report

    Report Number
    2017865-2014-15418
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    April 2, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION INCLUDED. FINAL ANALYSIS FOUND CLAVICLE CRUSH DAMAGING OUTER COIL AND INSULATION ABRASION AT 17.0 CM TO 17.8 CM FROM THE CONNECTOR PIN; CAUSING AN ELECTRICAL SHORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED LOW IMPEDANCE, OVERSENSING, LOSS OF CAPTURE. RIB CLAVICLE CRUSH DAMAGE WAS NOTED. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402749 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 2088TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention PM2210, 7455448