BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINED LEAD

    MDR report key: 921632 · Received September 21, 2007

    Report

    Report Number
    6000153-2007-03068
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Report Date
    March 2, 2005
    Manufacturer
    MPROC, VILLALBA
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION WHICH COVERS A 2-YEAR RETROSPECTIVE REVIEW OF EVENTS REPORTED BY CONSUMERS BETWEEN 2005 AND 2006 (INCLUSIVE). THIS EXEMPTION WAS GRANTED TO SATISFY MEDTRONIC'S MDR OBLIGATIONS FOR ANY PREVIOUSLY UNREPORTED SERIOUS INJURY, DEATH AND MALFUNCTION EVENTS FOUND DURING THIS REVIEW. THIS MEDWATCH REPORT REPRESENTS 3 UNREPORTED MALFUNCTION EVENTS FOR MODEL 3093, 1 UNREPORTED MALFUNCTION EVENT FOR MODEL 3889, AND 1 UNREPORTED MALFUNCTION EVENT FOR MODEL LEAD FOR THE ABOVE TIME PERIOD. (PRODUCT CODE EZW).

    Description of Event or Problem · 1

    PT HAD TRIAL YESTERDAY AND WHEN HE GOT UP, THE CABLE/WHITE CONNECTOR RIPPED OUT AND THE WIRE IS FRAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TINED LEAD EZW MPROC, VILLALBA 3093 J0454519V

    Patients

    Seq Age Sex Outcome Treatment
    1 YR EXPLANTED| IMPLANTABLE NEURO STIMULATOR MODEL 7427V | IMPLANTED| LOT# NFE406349H| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7427V| LOT# NFE406349H