BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PUMP

    MDR report key: 3232505 · Received July 18, 2013

    Report

    Report Number
    3007566237-2013-02384
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A ¿BATTERY CHANGE¿ BECAUSE THE ¿BATTERY DIED¿. NO PATIENT SYMPTOMS WERE REPORTED. THE MEDICATION DELIVERED BY THE DEVICE SYSTEM WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333351 UNKNOWN PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION UNKNOWN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention