BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3902646 · Received June 30, 2014

    Report

    Report Number
    6000153-2014-00124
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DOCTOR COMPLETED STAGE 2 ON THE DAY OF THE REPORT. THE PATIENT WAS STILL IN THE HOSPITAL AND THE NEXT STEP WAS UNKNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE LEFT HEMISPHERE WAS PROGRAMMED ON (B)(6) 2014 AND THE PATIENT RECEIVED THERAPY AND SHOWED POSITIVE SYMPTOM CONTROL FOR THEIR RIGHT ARM, LEG, AND FACE. THEY HAD A REDUCTION IN TREMOR AND RIGIDITY. THEY SLOWLY REGAINED MOVEMENT ON THEIR LEFT SIDE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EVENT TOOK PLACE 4 DAYS PRIOR TO REPORT. IT WAS NOTED THE TWO LEADS THAT WERE PLACED, ONE IN THE LEFT HEMISPHERE AND ONE IN THE RIGHT HEMISPHERE. DURING THE POST-OPERATIVE IMAGING, IT WAS DISCOVERED THAT THE LEAD IN THE RIGHT HEMISPHERE HAD PUNCTURED THE RIGHT VENTRICLE. IT WAS NOTED THE LEFT HEMISPHERE HAD NO ISSUE. THERE WAS A HEMORRHAGE AS WELL. AT THE TIME OF REPORT, THE BLEEDING HAD STOPPED AND THE PATIENT DID HAVE SOME IMPROVEMENT ON BOTH LEFT AND RIGHT SIDES. IT WAS FURTHER REPORTED NO TROUBLESHOOTING WAS DONE AND THE PATIENT WAS STILL IN THE INTENSIVE CARE UNIT (ICU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380621 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3387S-40 VA0HZ0B

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O