BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3222483 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11650
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME INTO THE CLINIC WITH A GRANULOMA AT THE CATHETER SITE. THE PATIENT WAS HOSPITALIZED AND AN OPERATION WAS PERFORMED TO RELOCATE THE CATHETER. IT WAS STATED THAT THE PUMP WAS DELIVERING HYDROMORPHONE AND PRIALT INTRATHECALLY. IT WAS STATED THAT THE PHYSICIAN CONFIRMED THAT THE GRANULOMA WAS CAUSED BY THE HYDROMORPHONE. IT WAS REPORTED THAT THE PATIENT WOULD BE SWITCHED TO MONOTHERAPY WITH PRIALT. THIRTEEN DAYS LATER, IT WAS REPORTED THAT THE PUMP WAS INITIALLY FILLED WITH HYDROMORPHONE ONLY, BUT PRIALT WAS ADDED ON (B)(6) 2012. IT WAS STATED THAT THE GRANULOMA WAS VISIBLE AND THE CATHETER HAD BEEN OCCLUDED. AT THE END OF (B)(6) 2013, THE PATIENT UNDERWENT A LAMINECTOMY TO REMOVE THE CATHETER TIP GRANULOMA. THE SPINAL SEGMENT OF THE CATHETER WAS PULLED BACK AND SHORTENED. IT WAS ALSO NOTED THAT HE PATIENT PRESENTED WITH INCREASED SPASTICITY, SO LIORESAL WAS ADDED TO THE PUMP IN (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322678 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R