BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 3923977 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14907
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 7, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: FINAL ANALYSIS FOUND INSULATION ABRADED AT 23.0 CM TO 24.0 CM EXPOSING OUTER COIL FROM THE CONNECTOR PIN. THE ABRASION WAS CONSISTENT WITH THAT OF EXPOSURE TO FRICTION WITH ANOTHER IMPLANTABLE DEVICE. THIS COULD MOST LIKELY CAUSE THE REPORTED COMPLAINT OF NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT WAS PRESENTED IN CLINIC. UPON INTERROGATION, STORED EPISODES OF VENTRICULAR NOISE REVERSION WERE NOTED. THE DEVICE WAS REPROGRAMMED. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401821 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1888TC/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention