BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4090017 · Received September 15, 2014

    Report

    Report Number
    3007566237-2014-02587
    Event Type
    Injury
    Date Received
    September 15, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NUMEROUS PROBLEMS WITH THE PUMP. THE PATIENT HAD BEEN UNDERDOSED, ENDURED PAIN, AND HAD BEEN OVERDOSED. THE PATIENT HAD FALLEN AND HAD BEEN TAKEN TO THE EMERGENCY ROOM (ER) NUMEROUS TIMES; INCLUDING A BROKEN HIP AND A BROKEN ARM (TWICE). THE PATIENT HAD PROBLEMS WITH ¿BLOCKAGE IN THE MECHANISM AT LEAST TWO TIMES¿ AND REPORTEDLY HAD TO BE TAKEN DIRECTLY FROM THE CLINIC TO THE ER ON AT LEAST ONE OCCASION WHEN THE ¿PUMP HAD TO BE CLEARED¿. IT WAS ALSO NOTED THAT THE PATIENT SUFFERED. THE MEDICATION IN THE PUMP AT THE TIME OF THE EVENT WAS NOT SPECIFIED. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT.  SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569927 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Other