BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3202438 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11193
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 10, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3387S-40 LOT# V325832, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40 LOT# V314995, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A40 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED THAT ON THE DAY OF THIS REPORT, THE PATIENT WAS IN THE EMERGENCY ROOM (ER) WITH A RETURN OF MOVEMENT DISORDER SYMPTOMS. IT WAS NOTED THAT AN END OF SERVICE (EOS) MESSAGE WAS DISPLAYED. THE REPORTER THOUGHT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED THREE MONTHS AGO BUT IT WAS ¿SECOND HAND INFORMATION.¿ IT WAS NOTED THAT THE REPORTER ¿DID NOT KNOW ANY OTHER REASON WHY THAT WOULD BE SINCE IT WAS SO EARLY.¿ IT WAS NOTED THAT ¿HE HAD IN THE PAST SET IT ON A FAIRLY HIGH VOLTAGE ¿ 4 VOLTS.¿ IT WAS FURTHER NOTED, THE PATIENT DID NOT ¿HAVE A HIGH PULSE WIDTH, A FREQUENCY 90 AND 80.¿ ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302057 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR