BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2760691 · Received September 26, 2012

    Report

    Report Number
    3007566237-2012-02320
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 5, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, LOT# N183229006, IMPLANTED: 2009-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2003-(B)(6), PRODUCT TYPE CATHETER. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CATHETER REVISION DONE IN ORDER TO PROVIDE 'MORE BENEFIT TO UPPER EXTREMITIES DUE TO SPASTICITY'. THE CATHETER REVISION TOOK PLACE ON (B)(6) 2012. THE SYSTEM WAS WORKING FINE EXCEPT, BUT THE PATIENT WANTED MORE BENEFIT TO THE UPPER BODY. DURING THE CATHETER REVISION, THE SPINAL PORTION OF THE CATHETER WAS REMOVED AND REPLACED WITH A LONGER PORTION. THE OUTCOME IS NOT KNOWN AT THIS TIME AS THE PATIENT WAS DISCHARGED AFTER THE PROCEDURE. IT WAS NOTED THAT THE PATIENT'S PUMP HAD BOTH BACLOFEN AND MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention