BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3203541 · Received July 3, 2013

    Report

    Report Number
    3007566237-2013-01144
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    August 14, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS EXPLANTED DUE TO A MOTOR STALL. THE REPORTER SAID THAT THE PATIENT THOUGHT SHE HAD A BLADDER INFECTION SO SHE WAS TREATING THAT FOR TWO WEEKS. THE PATIENT CONTACTED THE HEALTH CARE PROVIDER (HCP) AFTER TWO WEEKS WHEN IT DID NOT SEEM LIKE IT WAS WORKING. THE REPORTER SAID IT ¿ENDED UP BEING A PUMP STALL¿. THE PATIENT WAS DIRECTED TO COME IN FOR THE HCP TO CHECK IT OUT. THE HCP ¿DID A PUMP ROLL¿ AND SURE ENOUGH IT STALLED. THE HCP CHECKED THE VOLUME WHICH SEEMED TO CONFIRM THE STALL. THE PATIENT WAS ASKED IF SHE HAD ANY OTHER SYMPTOMS OTHER THAN INCREASED SPASTICITY. THE HCP ASKED THE PATIENT ¿DID YOU NOT HAVE ANY HALLUCINATIONS, YOU KNOW, AUDITORY, YOU KNOW, WHATEVER, RIGHT? SOMETHING UNUSUAL? ¿, AND IT WAS REPORTED THAT THE PATIENT REPLIED ¿WELL, NOW WHEN YOU THINK ABOUT IT, IT FELT LIKE A REAL DREAM THAT HER CAREGIVER BECAUSE SHE LIVES--SHE SLEEPS IN A HOSPITAL BED--WAS LAUGHING HYSTERICALLY WITH THIS REALLY EVIL SMILE, UM, AND PUTTING THE BED UP TOWARDS THE CEILING AND THEN PUTTING IT DOWN. I SAID WELL, THAT WASN'T A DREAM.¿ THE REPORTER SAID ¿IT WAS A HALLUCINATION LIKE, UM, LIKE A NIGHTMARE¿, AND THE REPORTER WONDERED IF THE PATIENT WAS ¿AFFECTED A LITTLE BIT COGNITIVELY IT JUST DOESN'T QUITE SINK IN.¿ THE REPORTER DID NOT KNOW IF THE PATIENT¿S TEMPERATURE WAS ¿UP¿ AT THE TIME OF THE HALLUCINATION. THE REPORTER SAID THAT SHE CALLED UP THE SURGEON RIGHT AWAY AND IT DID GET REPLACED AND THAT WAS A NUMBER OF YEARS AGO. THE DRUG USED IN THE PUMP WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303947 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention