BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3214967 · Received July 10, 2013

    Report

    Report Number
    3004209178-2013-11533
    Event Type
    Malfunction
    Date Received
    July 10, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 64002, LOT# N275881, IMPLANTED: (B)(6) 2011: PRODUCT TYPE ADAPTER; PRODUCT ID 37642, SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID 7482002102, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007: PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V023690, IMPLANTED: (B)(6) 2007: PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007: PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V040134, IMPLANTED: (B)(6) 2007: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT 4 DAYS PRIOR TO THE REPORT ON (B)(6) 2013, THE PATIENT GOT THE "CALL YOUR DOCTOR" ICON AND END OF SERVICE (EOS) ON THE PROGRAMMER. THE PATIENT REPORTED THAT HE WAS IMPLANTED (B)(6) 2011 AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ALREADY DEAD. THE PATIENT REPORTED THAT HIS LAST INS LASTED FOR ABOUT 4 YEARS OR FOUR AND A HALF YEARS AND THIS ONE HAD LASTED TWO. IT WAS NOTED THAT THE PATIENT STOPPED FEELING STIMULATION ABOUT FOUR DAYS PRIOR TO THE REPORT. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318485 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR