BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2868610 · Received December 11, 2012

    Report

    Report Number
    3004209178-2012-11719
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Report Date
    November 21, 2012
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION DEVICE USED FOR WAS MRU. PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 64001, LOT # N247530, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ADAPTER; PRODUCT ID 37651, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387S-40, LOT # V139132, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE WAS TURNED OFF AND THE REPORTER STATED THEY WERE NOT SURE HOW THE DEVICE GOT TURNED OFF. THE REPORTER STATED THAT THE DEVICE CHARGE LEVEL WAS NOT GOING DOWN AND THIS MAY HAVE BEEN DUE TO THE DEVICE BEING TURNED OFF. IT WAS NOTED THAT THE THERAPY WAS HELPING WITH THE PATIENT'S SYMPTOMS. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IN ADDITION TO THE PREVIOUSLY REPORTED INFORMATION, IT WAS REPORTED THE PATIENT PROGRAMMER WAS IN ICON MODE INSTEAD OF TEXT MODE. IT WAS UNKNOWN THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF FOR TWO WEEKS. AFTER SWITCHING THE PATIENT PROGRAMMER BACK INTO TEXT MODE THE INS WAS SUCCESSFULLY TURNED BACK ON. AFTER THE INS WAS TURNED BACK ON IT WAS ALSO REPORTED THE PATIENT WAS HAVING SOME "TWITCHING WITH HIS EYES.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1