BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 3924082 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-15008
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 27, 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 FOLLOWING IMPLANT, THE VENTRICULAR LEAD EXHIBITED HIGH IMPEDANCE. THE POCKET WAS RE-OPENED AND THE LEAD WAS REPOSITIONED TO A SUITABLE POSITION. THE LEAD REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399643 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 2088TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention PM2114 2909703