BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE PUMP

    MDR report key: 4240575 · Received November 10, 2014

    Report

    Report Number
    3007566237-2014-03275
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 27, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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 PROFESSIONAL (HCP) REPORTED THAT THEY HAD A PUMP FAILURE TWO WEEKS PRIOR TO THE REPORT. DRUG INFORMATION, CAUSE OF THE PUMP FAILURE, PATIENT SYMPTOMS, INTERVENTIONS, AND PATIENT OUTCOME WERE NOT PROVIDED. THIS INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723294 UNKNOWN IMPLANTABLE PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1