BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEU_UNKNOWN_PUMP

    MDR report key: 3083266 · Received April 29, 2013

    Report

    Report Number
    3007566237-2013-01466
    Event Type
    Malfunction
    Date Received
    April 29, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A PROBLEM WITH THE BATTERY IN HIS PUMP. THE PATIENT STATED THAT THE PUMP WAS RECALLED. THE MEDICATION DELIVERED BY THE DEVICE SYSTEM WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185894 NEU_UNKNOWN_PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1