BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

    MDR report key: 2883638 · Received December 21, 2012

    Report

    Report Number
    3007566237-2012-03096
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A FAMILY MEMBER/FRIEND THAT "ONE TIME THE THING FLIPPED, SO THEY HAD TO GO IN AND CHANGE IT OUT." THE REPORTER COULD NOT REMEMBER IF IT WAS THE FIRST OR SECOND PUMP, THE DATE WAS ALSO UNKNOWN. IT WAS LATER REPORTED BY HEALTHCARE PROVIDER (HCP) PATIENT "NEVER HAD A FLIPPED PUMP," THE PUMP WAS REPLACED IN (B)(6) 2012 DUE TO MOTOR STALLS. IT IS UNKNOWN IF THE FLIPPED PUMP AND MOTOR STALL OCCURRED ON THE SAME DEVICE, PLEASE SEE REPORT 3004209178-2012-05774 REGARDING MOTOR STALL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention