BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1080742 · Received July 23, 2008

    Report

    Report Number
    3004209178-2008-04265
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS "NOT WORKING". TESTING SHOWED HIGH IMPEDANCE IN ALL OF THE LEADS. DURING THE REVISION SURGERY A NEW GENERATOR WAS ATTACHED TO THE EXISTING LEADS AND THE PT COULD NOT FEEL ANY STIMULATION. THE COMPLETE SYSTEM WAS REPLACED. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| LEAD MODEL# 3093 LOT# V009140| EXPLANTED