BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1001717 · Received February 15, 2008

    Report

    Report Number
    2182207-2008-00724
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    December 1, 2007
    Report Date
    January 18, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE HCP INITIALLY REPORTED HAVING DIFFICULTY ACCESSING THE PORT DURING A REFILL OF THE PT'S INTRATHECAL DRUG DELIVERY PUMP. ADD'L INFO FROM THE HCP INDICATED AN X-RAY OF THE PUMP REVEALED THE PUMP HAD FLIPPED IN THE POCKET. THE PT UNDERWENT SURGERY TO CORRECT THE PROBLEM APPROX ONE MONTH LATER. SURGICAL EXPLORATION REVEALED TWO OF THE TACK DOWN SUTURES HAD BROKEN CAUSING THE PUMP TO FLIP, RESULTING IN THE CATHETER BEING TWISTED MULTIPLE TIMES. THE DRUG USED IN THE PUMP IS INFUMORPH 10 MG/ML AT A DOSE OF 2.5 MG/DAY. THE HCP REPORTED THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| PROGRAMMER MODEL 8840| EXPLANTED| CATHETER MODEL 8711