BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 2983839 · Received February 28, 2013

    Report

    Report Number
    2017865-2013-01484
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 9, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE PULSE GENERATOR CHANGE OUT, THE PHYSICIAN NOTED THE RIGHT VENTRICULAR LEAD EXHIBITED AN INSULATION ANOMALY. THE LEAD DID NOT EXHIBIT ELECTRICAL ANOMALIES. THE LEAD REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87958 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1788TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 101 YR