BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2781424 · Received October 10, 2012

    Report

    Report Number
    3004209178-2012-09088
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Report Date
    September 17, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW, IT WAS FOUND THAT THE FOLLOWING PRODUCT SHOULD HAVE BEEN ADDED TO CONCOMITANT PRODUCTS: PRODUCT ID: NEU_ADAPTOR_ACC; PRODUCT TYPE ACCESSORY.

    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 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3387S-40, LOT# V025540, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 3387S-40, LOT# V020186, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPEDANCE OUT OF RANGE WAS FOUND (1 MONTH TO A YEAR AND A HALF AFTER A NEW IMPLANTABLE NEUROSTIMULATOR WAS PLACED USING AN ADAPTOR). IT WAS UNCLEAR THAT IF IT WAS CAUSED BY THE OPEN/CLOSE CIRCUITS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1