BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX LEAD

    MDR report key: 6602691 · Received May 31, 2017

    Report

    Report Number
    2017865-2017-04161
    Event Type
    Malfunction
    Date Received
    May 31, 2017
    Date of Event
    May 26, 2017
    Report Date
    June 14, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND AN INSULATION ABRASION THAT BREACHED THE INSULATION AT 6.8 CM TO 7.0 CM FROM THE CONNECTOR PIN. ABRASIONS ARE CONSISTENT WITH CONSTANT FRICTION WITH ANOTHER DEVICE.

    Additional Manufacturer Narrative · 1

    SHOULD HAVE BEEN TENDRIL SDX LEAD, RATHER THAN BLANK. LOT # SHOULD HAVE BEEN 0002402490 RATHER THAN BLANK.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384023 TENDRIL SDX LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1488TC/52 0002402490

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR