BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3701717 · Received March 26, 2014

    Report

    Report Number
    3004209178-2014-05092
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Report Date
    March 6, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387-40, LOT# V003110, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT# V001519, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POWER ON RESET (POR) CONDITION. THE POR CODE WAS UNKNOWN. IT WAS BELIEVED THAT THE POR CODE DID HAVE A 4 IN IT OR POSSIBLY A 400. IT WAS NOTED THAT THE POR HAD TURNED THE IMPLANTABLE NEUROSTIMULATOR (INS) OFF. THIS HAD OCCURRED ABOUT A WEEK PRIOR TO THE DATE OF THIS REPORT. IT WAS NOTED THAT THIS HAD HAPPENED DURING THE DAY AND PATIENT TURNS DEVICE OFF AT NIGHT. IMPEDANCES WERE GOOD. THE CAUSE OF REASON FOR THE POR WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177644 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR