BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_UNKNOWN_PUMP

    MDR report key: 3203504 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01065
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    August 13, 2012
    Report Date
    August 13, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    IT WAS REPORTED THAT A PUMP REVISION WAS PLANNED BECAUSE THERE HAD BEEN FLUID BUILD UP AROUND THE PUMP. THE PATIENT OUTCOME REMAINS UNKNOWN. THE DRUG BEING USED IN THE PUMP WAS UNKNOWN. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302807 NEU_UNKNOWN_PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention