BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3172928 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10449
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    February 8, 2010
    Report Date
    September 24, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    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

    PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION, PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V345973, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V345973, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED HEADACHE AND SENSATION OF INTERNAL TREMOR AND THE CALLER WANTED COMPATIBILITY GUIDELINES FOR EEG AND EKG. IT WAS STATED THE PATIENT HAD ¿TREMENDOUS AFFECT FROM HIS IMPLANTABLE NEUROSTIMULATOR(INS)¿ AS HE PLAYS IN THE (B)(6). THE HEALTHCARE PROVIDER (HCP) WAS TREATING THE PATIENT WITH BIOFEEDBACK FOR HIS CHRONIC HEADACHE AND INTERNAL SENSATION OF TREMOR. IT WAS STATED DURING BIOFEEDBACK/EEG SESSIONS WITH CALLER, HE WAS SEEING SIGNALS IN VARIOUS FREQUENCY AND WONDERING IF THIS COULD BE COMING FROM DBS. IT WAS REVIEWED THIS TYPE OF INTERACTION WAS SEEN WITH SENSING AND MONITORING EQUIPMENT. IT WAS NOTED THEY HAD NOT TRIED SHUTTING STIMULATION OFF DURING THESE SESSIONS YET BUT WILL TO SEE IF THAT TAKES AWAY THIS OTHER INPUT SEEN. REPORTEDLY, THE PATIENT HAD DEVELOPED HEADACHE AND INTERNAL SENSE OF TREMOR SINCE HE HAD HIS IMPLANT. IT WAS STATED THE PATIENT¿S HEADACHE BEGAN ABOUT ONE YEAR PRIOR TO REPORT WHERE THE PATIENT WAS ¿FOGGY HEADED AND HAD A BAD HEADACHE AND THEY THOUGHT IT WAS A STROKE.¿ IT WAS STATED THE SYMPTOMS CLEARED UP BUT THE PATIENT CONTINUED TO HAVE HEADACHES SINCE THEN. IT WAS NOT KNOWN IF TURNING ON STIMULATION AFFECTED INTERNAL TREMORS OR HEADACHE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274180 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Other