BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2834089 · Received November 15, 2012

    Report

    Report Number
    3007566237-2012-02726
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8840, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID 8709, LOT# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP WAS USED TO DELIVER CLONIDINE AND MORPHINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CATHETER DISLODGEMENT/MIGRATION. IT WAS CONFIRMED VIA X-RAY THAT THE SPINAL SEGMENT WAS DISLODGED OUT OF THE INTRATHECAL SPACE. THE PATIENT EXPERIENCED A LOSS OF THERAPY WITH INCREASED PAIN. THE PATIENT WAS SUPPLEMENTED WITH ORAL MEDICATION UNTIL REVISION OCCURRED AND DID WELL WITH THAT. REVISION WAS PERFORMED WITH ADDITION OF THE SPINAL SEGMENT ONLY. THE PATIENT WAS STARTED ON A DAILY DOSE OF 2.160MG WITH CONTINUED SUPPLEMENTED MEDICATION. IT WAS REPORTED THAT THE PATIENT WAS NOW RECEIVING EFFECTIVE THERAPY. THE CATHETER WAS SENT TO PATHOLOGY ONLY. THE DRUG DELIVERED VIA PUMP WAS MORPHINE.

    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