BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 1902221 · Received November 15, 2010

    Report

    Report Number
    3007566237-2010-09533
    Event Type
    Injury
    Date Received
    November 15, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A ROUTINE PUMP REPLACEMENT. AN X-RAY OF THE CATHETER WAS TAKEN A DAY BEFORE THE PROCEDURE AS THE PATIENT HAD BEEN ON A HIGH DOSE OF MEDICATION AT 1400 MCG/DAY. THE MEDICATION WAS NOT SPECIFIED. THE PATIENT'S DOSE WAS OVER 1000 MCG/DAY FOR YEARS AND THE PATIENT BELIEVED THE THERAPY WAS EFFECTIVE SO NOTHING HAD BEEN INVESTIGATED PREVIOUSLY. THE X-RAY SHOWED THAT THE CATHETER WAS "POINTING DOWN". WHEN THE CATHETER WAS INVESTIGATED SURGICALLY, IT SEEMED TO HAVE A COMPLETE SEPARATION DISTAL TO THE ANCHOR. THE CATHETER WAS REPLACED AND THE MEDICATION DOSE WAS LOWERED TO 300MCG/DAY SINCE IT WAS UNCLEAR IF THE PATIENT WAS RECEIVING THE MEDICATION OR NOT. THE PLAN WAS TO TITRATE UP AS NECESSARY IN THE COMING DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# UNKNOWN