BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 4520657 · Received February 17, 2015

    Report

    Report Number
    3007566237-2015-00364
    Event Type
    Injury
    Date Received
    February 17, 2015
    Date of Event
    May 1, 2014
    Report Date
    January 27, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2014, THE PATIENT HAD THE PUMP REPLACED BECAUSE THE PATIENT FELL AND IT STOPPED WORKING. WHEN THE PATIENT FELL, THE PATIENT¿S LEG JUST TURNED BLUE AND THEIR LEG JUST STARTED SHAKING, IT BENT DOWN AND WAS REALLY BAD. IT HURT A LOT. IT WAS DETERMINED THAT THE PATIENT HAD A MALFUNCTION IN THE IT CATHETER. THE PATIENT¿S PUMP BATTERY WAS REACHING END OF LIFE. THE PATIENT HAD THE PUMP AND CATHETER REPLACED. 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. THE PUMP WAS USED TO DELIVER PRIALT. PATIENT OUTCOME NOT REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112957 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention