BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3686196 · Received March 18, 2014

    Report

    Report Number
    3007566237-2014-00721
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Report Date
    February 18, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    IT WAS REPORTED THAT THE PATIENT HAS HAD A ¿NUMBER OF PROBLEMS¿ (WHICH THE PATIENT DID NOT SPECIFY) ON WEEKENDS AND THE HEALTH CARE PROVIDERS (HCP) WERE NOT AVAILABLE. THE PATIENT STATED THE COMPANY DID NOT HAVE ENOUGH AFFILIATED HEALTH CARE PROVIDERS AND THE HCP¿S DO NOT HAVE A HOSPITAL OR ARE NOT AVAILABLE ON THE WEEKENDS. THE HOSPITALS DO NOT KNOW ABOUT THE DEVICE AND ¿THINK THE PATIENT JUST WANTS DRUGS.¿ REPORTEDLY, THE HCP HAD TRIED NUMEROUS DRUGS THAT DID NOT WORK AND CURRENTLY THE PATIENT HAS A ¿COCKTAIL.¿ THE PATIENT WAS CONSIDERING HAVING THE PUMP REMOVED AND ALSO THOUGHT ABOUT MOVING TO (B)(6). HE REQUESTED A PHYSICIAN LISTING AS THE HEALTH CARE PROVIDER (HCP) THE PATIENT CALLED DID NOT DO ¿COCKTAILS.¿ THE PATIENT WAS ALSO TAKING ORAL MEDICATIONS. IT WAS NOT KNOWN WHAT MEDICATION THIS DEVICE SYSTEM DELIVERED AT THE TIME OF THESE ¿PROBLEMS.¿ HOWEVER, CURRENTLY THE DEVICE SYSTEM DELIVERED SUFENTANIL, CLONIDINE, BUPIVACAINE, AND BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159542 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR