BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4202667 · Received October 27, 2014

    Report

    Report Number
    3007566237-2014-03119
    Event Type
    Injury
    Date Received
    October 27, 2014
    Report Date
    October 6, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING SITE ID WAS PREVIOUSLY REPORTED AS 3007566237. ADDITIONAL REVIEW INDICATES THE CORRECT MANUFACTURING SITE ID IS 9614453.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD DISLOCATED AND MOVED IN THE POCKET APPROXIMATELY ON (B)(6) 2013. A REVISION WAS PERFORMED TO CORRECTLY POSITION THE INS. IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS. NO OUTCOME WAS PROVIDED REGARDING THE EVENT. FURTHER FOLLOW UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS DOING WELL FOLLOWING THE REVISION. THEY WERE RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683699 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention