BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE PUMP

    MDR report key: 3080879 · Received April 26, 2013

    Report

    Report Number
    3007566237-2013-01444
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    A HEALTHCARE PROVIDER REPORTED THAT SHE HAD A PUMP STALL IN THE PAST. THE CAUSE OF THE STALL, AND WHETHER OR NOT IT RECOVERED WAS NOT REPORTED. NO PATIENT SYMPTOMS WERE REPORTED. THE MEDICATION USED WITHIN THE SYSTEM WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183238 UNKNOWN IMPLANTABLE PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1