BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE PUMP

    MDR report key: 3981459 · Received August 5, 2014

    Report

    Report Number
    3007566237-2014-02186
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS ONLINE AND SAW THAT OTHER PEOPLE HAVE HAD ¿THIS PROBLEM¿ (REFER TO MANUFACTURER REPORT # 3004209178-2014-13977 FOR THE KNOWN PATIENT¿S PROBLEM) WHICH WAS REFERRING TO PATIENT¿S STOMACHS ¿BUSTING¿ OPEN. NO FURTHER INFORMATION WAS PROVIDED. 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
    456335 UNKNOWN IMPLANTABLE PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other