BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1172981 · Received September 19, 2008

    Report

    Report Number
    3004209178-2008-05961
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Report Date
    August 21, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT LOST STIMULATION. THE PATIENT HAD CHIROPRACTOR SESSIONS ON HER NECK AND HIP. THE IMPEDANCE MEASUREMENTS WERE GREATER THAN 4,000 OHMS. FURTHER INFORMATION 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 IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3067| LEAD: MODEL 3889