BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4459632 · Received January 28, 2015

    Report

    Report Number
    3004209178-2015-01322
    Event Type
    Malfunction
    Date Received
    January 28, 2015
    Report Date
    January 7, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR OFF LABEL INDICATION OF TOURETTE¿S. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V014191, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V014191, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED FOR TOURETTE¿S SYMPTOMS AND NEW TO THE HEALTHCARE PROVIDER¿S (HCP) PRACTICE. ONE WEEK PRIOR TO THE REPORT THE PATIENT HAD INCREASING ¿TIC¿ SYMPTOMS, BUT WAS NOT BACK TO HIS BASELINE BEFORE IMPLANT. PRIOR TO ANY CURRENT CHANGES, THE HCP SAW AN OUT OF REGULATION (OOR) MESSAGE ON THE LEFT BRAIN. WHEN THE HCP ATTEMPTED TO INCREASE THE LEFT BRAIN BY 0.3 MILLIAMPERES IN CONSTANT CURRENT, SHE SAW AN OOR MESSAGE AS WELL. THE HCP ATTEMPTED TO INCREASE THE LEFT BRAIN FIRST, WHICH CONTINUED TO SHOW AN OOR MESSAGE, AND WAS ABLE TO INCREASE THE RIGHT BRAIN WITHOUT ANY ISSUE. THE IMPEDANCES WERE MEASURED, EVEN WITH PATIENT HEAD MOVEMENT, AND WERE WITHIN THE NORMAL RANGE. IT WAS NOTED THAT WHEN THE PATIENT WAS SEEN FOUR WEEKS PRIOR TO THE REPORT THEY WERE HAVING THE SAME ISSUE. DURING THE REPORT THE PATIENT NOTICED PERSISTENT SYMPTOMS ON THE RIGHT BRAIN, SO THE HCP REPROGRAMMED BOTH BRAINS DOWN TO 4.8 MILLIVOLTS; HE HAD ARRIVED AT 4.8 MILLIAMPERES ON BOTH SIDES, AND INCREASED HIS FREQUENCY. NO INTERVENTIONS OR PATIENT OUTCOME WERE REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64309 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1