BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 1201518 · Received October 17, 2008

    Report

    Report Number
    2182207-2008-06628
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 19, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL (HCP) SET PROGRAM TO .5 VOLTS AND THE PROGRAMMER CHANGED THE SETTING TO 5.5 VOLTS; THE HCP STATED THAT SHE USED THE WHEEL TO CHANGE THE SETTING. AFTER HITTING PROGRAM, THE HCP STATED THAT THE PATIENT WAS SHOCKED; MORE ENERGY WAS DELIVERED THAN EXPECTED TO THE PATIENT. THE HCP TRIED USING THE RED HOT KEY TO SHUT IT OFF AND IT DIDN'T WORK. THE PROGRAMMER WAS REPLACED. THE PATIENT WAS DOING OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN IMPLANTABLE NEUROSTIMULATOR MHY MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 PROGRAMMER MODEL 8840 LOT# UNK| IMPLANTED:| LEAD MODEL UNK| EXPLANTED: