BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2992524 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03436
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 14, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 3387S-40, LOT# VA02BM6, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S DEVICE TURNED OFF. THE PATIENT WAS USING A CURLING IRON AND "SOMETHING HAPPENED WHERE THE STIMULATOR WENT INTO THE OFF POSITION." IT WAS NOT NOTICED THAT DEVICE WAS OFF UNTIL LATER IN THE DAY. THE PATIENT'S HUSBAND WAS ABLE TO TURN THE DEVICE BACK ON. THE PATIENT HAD NOT GONE ANYWHERE OR DONE ANYTHING THE DAY OF EVENT, HOWEVER, IT WAS NOTED THE PATIENT HAD BEEN AT THE MALL AND HAD BEEN TO SEVERAL STORES THE DAY BEFORE. IT WAS ALSO NOTED THE PATIENT'S HUSBAND MAY HAVE TOUCHED THE OFF BUTTON WHEN USING THE PATIENT PROGRAMMER BUT IT WAS NOTED THE PATIENT'S SYMPTOMS BEGAN PRIOR TO USING THE PATIENT PROGRAMMER. THE PATIENT GOT "TOTALLY SICK" COULD NOT FUNCTION, WALK, DRINK, OR SWALLOW. THE PATIENT PROGRESSIVELY SICK THROUGHOUT THE DAY AND HAD TO BE TAKEN TO THE EMERGENCY ROOM. THE DEVICE WAS TURNED BACK ON AND THE PATIENT HAD GRADUAL RELIEF OF THEIR SYMPTOMS OVER A FEW HOURS. PATIENT HAD NOT HAD ANY ISSUES SINCE THE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW REPORTED THAT OTHER THAN THE SYMPTOMS REPORTED PREVIOUSLY, THE PATIENT ALSO FELT WEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98120 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1