BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3091954 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07240
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 21, 2013
    Report Date
    April 22, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37602, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN_EXT, SERIAL # UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL # UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT'S SYMPTOMS RETURNED ON THE NIGHT OF (B)(6). THE PATIENT'S INS ON THE RIGHT SIDE SHOWED THAT IT WAS ON AND OK. THE PATIENT'S INS ON THE LEFT SIDE SHOWED THAT IT WAS OFF AND OK. THE PATIENT TURNED THE LEFT SIDE INS ON AND CONFIRMED THAT IT SHOWED ON AND OK. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194818 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR