BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 4520684 · Received February 17, 2015

    Report

    Report Number
    3007566237-2015-00365
    Event Type
    Injury
    Date Received
    February 17, 2015
    Date of Event
    September 1, 2010
    Report Date
    January 27, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID NEU_UNKNOWN_CATH, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT TOOK ABOUT A YEAR FOR THE PATIENT TO GET OPTIMAL TREATMENT WITH PRIALT. AT FIRST, (IN (B)(6) 2010), THE PATIENT¿S PRIALT DOSAGE WAS TOO HIGH THAT THE PATIENT STARTED TO GET SIDE EFFECTS, THE PATIENT STARTED HEARING NOISES AND JUST FELT LIKE THE RADIO WAS ON OR PEOPLE TALKING IN THE OTHER ROOM. THE PATIENT THOUGHT IT WAS HER KIDS TALKING BUT WHEN SHE WOULD GO CHECK THEY WERE SOUND ASLEEP. IT FELT LIKE THE RADIO WAS ON, SHE WOULD SMACK THE ALARM TO STOP THE RADIO, BUT IT WASN¿T ON, IT WAS JUST GOING ON IN HER HEAD. THE PATIENT¿S HEALTHCARE PROVIDER SAID LET¿S TURN IT DOWN SOME. THE HEALTHCARE PROVIDER TURNED THE DOSAGE DOWN AND THE SYMPTOMS RESOLVED. THAT¿S WHEN THE PATIENT COULD PUT HER FEET ON THE GROUND AGAIN AND BEAR WEIGHT, GOT SHOES ON, COULD STAND UP AND NO LONGER WOULD HAVE TO STAY IN THE WHEELCHAIR. THE ONLY THING THAT FIXED HER LEG AND SHOWED ACTUAL IMPROVEMENT WAS THE PRIALT, THE COLOR HAS CHANGED, THE SENSATION HAS CHANGED, SHE¿S SLEEPING, SHE¿S WALKING, SHE¿S DOING AMAZING, SHE¿S PLAYING BALL WITH HER KIDS, SHE¿S DOING EVERYTHING AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112524 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Other