BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3180727 · Received June 20, 2013

    Report

    Report Number
    9614453-2013-01442
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    May 26, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS ORIGINALLY IMPLANTED ON THE CHEST, BUT SOMETIME AFTER IMPLANT IT FLIPPED. IT WAS NOTED THAT THE INS HAD MOVED ¿ADJACENT TO THE PATIENT¿S CLAVICLE.¿ IT WAS NOTED THAT THIS WAS ¿VERY UNCOMFORTABLE¿ FOR THE PATIENT. IT WAS FURTHER NOTED THAT THE SYSTEM WAS OPERATING APPROPRIATELY. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT HAD SURGERY TO REPOSITION THE INS. IT WAS NOTED THAT THE SURGICAL TEAM FOUND THE INS WAS FLIPPED. THE INS WAS REPOSITIONED ACCORDINGLY AND WAS STITCHED DOWN. IT WAS NOTED THAT THE INS CONTINUED TO WORK EVEN THOUGH IT WAS FLIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280879 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention