BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2994095 · Received March 8, 2013

    Report

    Report Number
    3004209178-2013-03472
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Report Date
    February 15, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT# V078937, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V187428, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS 'TURNING OFF ON ITS OWN.' IT WAS FURTHER REPORTED THAT OF THE PATIENT'S TWO INSS, 'ONE TURNED OFF AND THE OTHER ONE DIDN'T.' WHICH DEVICE SPECIFICALLY TURNED OFF WAS UNKNOWN AT THE TIME OF REPORT. IT WAS ALSO REPORTED THAT THIS HAD OCCURRED 'TWICE.' EACH EPISODE WAS REPORTED TO HAVE OCCURRED WHILE THE PATIENT WAS SEATED IN THE FRONT SEAT OF AN AUTOMOBILE. IT WAS UNKNOWN WHETHER THE CAR WAS TURNED ON AT THE TIME OF EACH EVENT. IT WAS ALSO REPORTED THAT THE PATIENT 'FELT' HER INS TURN OFF AND WAS ABLE TO TURN IT BACK ON SUCCESSFULLY EACH TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. PLEASE SEE MFR REPORT # 3004209178-2013-03471 FOR INFORMATION ON THE PATIENT'S OTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99935 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1