BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1030966 · Received April 17, 2008

    Report

    Report Number
    6000153-2008-02023
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 17, 2008
    Manufacturer
    MPROC, VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPRESENTATIVE REPORTED THAT SYSTEM INTERROGATION HAD REVEALED HIGH IMPEDANCE READINGS; A VALUE OF 2700 OHMS HAD BEEN OBTAINED. THE PATIENT WAS NOT RECEIVING STIMULATION THERAPY CONTROL AND AN OPEN CIRCUIT WAS SUSPECTED. THERE HAD BEEN A LACK OF THERAPY BENEFIT REPORTED SINCE THE TIME OF SYSTEM PLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MPROC, VILLALBA UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other IMPLANTABLE PULSE GENERATOR MODEL UNK| IMPLANTED| EXPLANTED