BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2904904 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-00381
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 18, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V302055, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V191279, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENTS LEFT ARM HAD BEEN FEELING NUMB FOR ABOUT THREE WEEKS. IT WAS NOTED THE PATIENT HAD AN APPOINTMENT SCHEDULED. FOLLOW UP FROM THE HEALTH CARE PROVIDER REPORTED THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS NOTED ELECTRODES 0 AND 3 HAD LOW IMPEDANCES, ALL OTHER IMPEDANCES WERE NORMAL. IT WAS NOTED ELECTRODES 0 AND 3 WERE NOT IN USE. REPROGRAMMING WAS DONE, STIMULATION WAS INCREASED FROM 1.7 TO 1.8 AND PARESTHESIAS RESOLVED. THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11945 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1