BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3203520 · Received July 3, 2013

    Report

    Report Number
    3007566237-2013-01145
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Report Date
    August 13, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLANGE HAD FRACTURED ON A TWO-PIECE CATHETER SYSTEM THAT CAUSED LEAKAGE INTO THE PUMP POCKET. IT WAS STATED THAT THIS HAD HAPPENED ON A ¿COUPLE¿ OF THE TWO-PIECE CATHETERS. NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT. THE DEVICE SYSTEM WAS USED TO DELIVER AN UNKNOWN DRUG. THE PATIENT OUTCOME WAS UNKNOWN AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303800 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1