BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 2232211 · Received August 26, 2011

    Report

    Report Number
    MW5021927
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 26, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC QUADRIPOLAR ELECTRODE LEAD -SNS- -MODEL 3889 - (B)(4). COMPANY REP INDICATED THAT THIS WAS PROBABLY A LEAD ISSUE SINCE THE IMPEDANCE'S WERE READING HIGH, THEREBY DEPLETING THE BATTERY OF THE DEVICE -MEDTRONIC NEURO STIMULATOR INTERSTIM II MODEL 3058-MUCH QUICKER THAN EXPECTED. THE ORIGINAL INTERSTIM DEVICE WAS EXPLANTED ON (B)(6) 2011, HOWEVER THE QUADRIPOLAR LEAD WAS CAPPED AND RETAINED. A NEW DEVICE AND QUADRIPOLAR WIRE WERE PLACED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SNS - QUADRIPOLAR ELECTRODE LEAD 3889 LGW MEDTRONIC 3889

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization THE ORIGINAL INTERSTIM DEVICE WAS EXPLANTED ON