BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 3032574 · Received April 3, 2013

    Report

    Report Number
    3007566237-2013-00998
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    January 7, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS REMOVED BECAUSE "IT NEVER WORKED". THE PATIENT DID NOT HAVE THE SERIAL NUMBER FOR THE REMOVED PUMP. THE LAST PUMP WAS ONLY FILLED ONCE AND NEVER REFILLED BECAUSE "IT DID NOT WORK". THE PATIENT NOTED "IT CAUSED ME SO MUCH PROBLEMS". THE DRUG IN THE PUMP WAS NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136555 PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention