BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA PC

    MDR report key: 2101733 · Received May 10, 2011

    Report

    Report Number
    3004209178-2011-03369
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 21, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT WITH NOT BEING ABLE TO ADJUST STIMULATION AND THE AMPLITUDE WAS AT 0 VOLTS. IN FOLLOW UP REPORTING, IT WAS NOTED THAT THE HEALTH CARE PROVIDER INTERROGATED THE DEVICE ABOUT 10 DAYS PREVIOUS AND CHANGED NOTHING AS FAR AS HER SETTINGS. THE PATIENT CAME BACK TO SEE THE HEALTHCARE PROVIDER FOR EMG AND BOTOX INJECTIONS IN THE NECK 1 WEEK AGO (NO CAUTERY OF ANY TYPE DONE) AND THESE WENT WELL. THEY WERE NOWHERE NEAR HER WIRES OR BATTERY. THE PATIENT CALLED THE HEALTHCARE PROVIDER THIS WEEK TO SAY THAT HER R BODY HAD TURNED OFF (WHEN SHE BROUGHT THE PT PROGRAMMER TO HER CHEST, IT HAD READ 0 V, AND COULD NOT BE INCREASED OR DECREASED). SHE HAD NOT MADE ANY CHANGES TO HER PARAMETERS, AND THE HCP HAD NOT EITHER. WHEN THEY SAW HER 10 DAYS AGO, HER PROGRAMMING GAVE HER THE ABILITY TO TURN OFF AND INCREASE UP TO 0.4 V, AND THIS REMAINED THE SAME. A POR (POWER ON RESET) WAS NOTED. THE CAUSE OF THE EVENT WAS UNKNOWN. THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS. PATIENT SIGNS/SYMPTOMS WAS NOTED AS NONE. RIGHT VIM WAS UNAFFECTED AND THEY WERE ABLE TO RE-PROGRAM BACK TO USUAL SETTINGS WITHOUT DIFFICULTY. THE PATIENT HAD GOOD THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA PC MHY MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR