BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2826866 · Received November 9, 2012

    Report

    Report Number
    3007566237-2012-02674
    Event Type
    Injury
    Date Received
    November 9, 2012
    Report Date
    October 12, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: SERIAL #: (B)(4). (B)(4). AN 8709 40 DEGREE PUMP CONNECTOR AND A SEGMENT OF CATHETER WERE RETURNED FOR ANALYSIS. ANALYSIS OF THE SAME REVEALED A HOLE/TEAR AND A BROKEN CATHETER BODY WAS OBSERVED. THE MOST DISTAL END OF THE RETURNED CATHETER WAS FOUND TO BE JAGGED IN APPEARANCE AND WHEN VIEWED IN CROSS SECTION WAS OVAL IN SHAPE. THESE TWO OBSERVATIONS INDICATED THE CATHETER WAS POSSIBLY COMPRESSED IN THIS AREA AND THEN EVENTUALLY BROKE HERE. ALSO NOTED WAS A HOLE IN THE CATHETER CLOSE TO THE PUMP CONNECTOR PORTION. THE HOLE WAS UNDER THE STRAIN RELIEF SHROUD AND CORRESPONDED TO WHERE THE METAL PIN OF THE PUMP CONNECTOR CAME TO AN END. PATENCY TESTING SHOWED AN OCCLUSION, MOST LIKELY WAS RELATED TO DRIED DRUG INSIDE THE CATHETER. THE PUMP WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS REPLACED DUE TO EOS (END OF SERVICE). A CATHETER REVISION WAS ALSO PERFORMED AS THERE WAS A "CONCERN PATIENT WAS NOT RECEIVING" MEDICATION BECAUSE THEY HAD INCREASED SPASTICITY, DESPITE AN INCREASE IN MEDICATION DOSE. A DYE STUDY HAD BEEN PERFORMED AND WAS INCONCLUSIVE. WHEN THE CATHETER WAS REMOVED, A FRACTURE TO THE CATHETER WAS NOTED. THE MEDICATION THE PUMP WAS INFUSING WAS LIORESAL. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention