BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3032838 · Received April 3, 2013

    Report

    Report Number
    3007566237-2013-01000
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS RELOCATED AT SOME POINT AS THE PATIENT'S PANTS HAD RUBBED THE PUMP AND THIS HURT. IT WAS NOT KNOWN WHAT MEDICATION THIS DEVICE SYSTEM DELIVERED AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    THE HCP LATER REPORTED THAT THE PUMP WAS NEVER MOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137084 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention