BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 2081070 · Received April 14, 2011

    Report

    Report Number
    3007566237-2011-02806
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 8, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS BEING REPLACED FOR NORMAL BATTERY END OF LIFE. WHEN THE PHYSICIAN DISCONNECTED THE CATHETER FROM THE PUMP TO REPLACE THE PUMP, HE FOUND THE CATHETER BROKEN AT THE PROXIMAL END. THE PHYSICIAN CUT THE CATHETER, OPENED A NEW CATHETER, AND SUBSTITUTED THE PROXIMAL CATHETER SEGMENT CONNECTING IT TO THE NEW PUMP. THERE WAS REPORTED TO BE NO PT INJURY. THE PT WAS "WELL" FOLLOWING THE PROCEDURE.

    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 IMPLANTED| CATHETER: MODEL 8709, LOT # UNKNOWN| EXPLANTED: