BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3043537 · Received April 9, 2013

    Report

    Report Number
    3004209178-2013-04916
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER; PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD INCREASING BACK PAIN OVER THE LAST THREE TO FOUR MONTHS. IT WAS FURTHER NOTED THAT THE PATIENT HAD BEEN COMPLAINING A LOT A LOT OVER THE PAST MONTH ABOUT HER BACK HURTING "IN THE SPINE AREA¿. THE PATIENT HAD WAS SCHEDULED FOR AN APPOINTMENT ON (B)(6) 2013. THE PATIENT'S LEFT LEG WAS EXTENDED AND SHE WAS NOTED TO HAVE BEEN VERY SPASTIC. THE PATIENT'S MOTHER STATED THAT, "THE FACT THAT HER BACK WAS HURTING, SOMETHING WAS WRONG WITH THE PUMP, OR SOMETHING WAS WRONG WITH THE LINE TO HER SPINE." THE MEDICATION USED WITHIN THE SYSTEM WAS BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146420 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1