BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2958309 · Received February 13, 2013

    Report

    Report Number
    3004209178-2013-02580
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Report Date
    January 24, 2013
    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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID 64002, LOT# N295692, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: ADAPTER: PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3387S-40, LOT# V063567, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 3387S-40, LOT# V053450, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNABLE TO ADJUST STIMULATION AND A "CALL YOUR DOCTOR" ICON WAS SHOWING. IT WAS ALSO NOTED THERE WAS AN OUT OF REGULATION (OOR) CONDITION. THE PATIENT WAS ABLE TO GET PAST THE OOR AND THAT THEIR STIMULATION WAS ON. IT WAS NOTED THE PATIENT HAD NOT HAD ANY RECENT FALLS. THE PATIENT DID NOT HAVE A RETURN OF SYMPTOMS, JUST "HAD A BAD DAY AND THOUGHT TO CHECK IT OUT." FOLLOW UP REPORTED THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. FURTHER FOLLOW UP FROM THE HEALTH CARE PROVIDER REPORTED THE OOR MESSAGE WAS NEVER REPORTED TO THEIR OFFICE. THE HCP HAD NO DETAILS ON THE EVENT. PATIENT WAS LAST SEEN IN THE OFFICE (B)(6) 2012. STIMULATOR REPLACEMENT WAS DONE AND FOLLOW UP APPOINTMENT WAS NOTED FOR (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63035 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR