BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE PUMP

    MDR report key: 2891906 · Received December 31, 2012

    Report

    Report Number
    3007566237-2012-03165
    Event Type
    Injury
    Date Received
    December 31, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT THOUGHT HE HAD HAD AN OVERDOSE BECAUSE HE FELL. IT WAS REPORTED THAT THE PATIENT FELL DIRECTLY ON HIS PUMP AND BELIEVED THAT HE HAD 'GONE INTO OVERDOSE'. THE PATIENT WAS REPORTED TO BE DOING WELL AND THE MEDICATION WAS TO BE TITRATED TO THE DESIRED EFFECT. THE MEDICATIONS USED WITHIN THE SYSTEM WERE BUPIVACAINE AND DILAUDID. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other