BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE PUMP

    MDR report key: 3151536 · Received June 7, 2013

    Report

    Report Number
    3007566237-2013-01885
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER REPORTED THAT A PATIENT¿S CATHETER TIP WAS AT T8, AND WAS ¿A LITTLE HIGH¿. THEY NOTED THE PATIENT HAD FREQUENT EPISODES WHERE HE FELT THAT HE HAD INCREASED PAIN AND SYMPTOMS OF WITHDRAWING. AFTERWARDS, THE PATIENT FELT SYMPTOMS OF OVERDOSE WHERE HE WAS NAUSEATED, HAD THROWN UP, AND HAD A LOT OF ITCHING. THEIR HEALTHCARE PROVIDER NOTED IN THE LOGS THAT THE PATIENT HAD MULTIPLE STALLS. THE DURATION OF THE STALLS WAS UNKNOWN AS THEY ¿DID NOT REALLY LOOK AT THAT¿. WHEN THE PATIENT¿S NEXT REFILL WAS DONE, THEIR RESIDUAL VOLUME WAS EQUAL TO WHAT THEY THOUGHT IT WAS GOING TO BE. THE HCP FURTHER STATED THAT THE PATIENT HAD MULTIPLE ¿TURN-OFFS¿ THROUGHOUT THE MONTH. IT WAS LATER NOTED THAT THE PATIENT THAT FELT LIKE HE OVERDOSED AFTER HE ¿GOT A LOT OF PAIN¿. THE PATIENT WAS NOTED TO HAVE KNOWN THERE WAS A STALLING PROBLEM. THE MEDICATION USED WITHIN THE SYSTEM WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253093 UNKNOWN IMPLANTABLE PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1