BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3925588 · Received July 10, 2014

    Report

    Report Number
    3004209178-2014-12776
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN OVERDOSE. IT WAS REPORTED THAT THE PATIENT HAD A REFILL ON (B)(6) 2014 (FRIDAY) AND SINCE THE PATIENT¿S LEG THAT IT HAD HELPED FELT REAL WEAK, ¿BUT IT COULD BE JUST ME TOO.¿ IT WAS NOTED THAT THE PATIENT DID NOT KNOW IF IT WAS BECAUSE THEY ¿HAD NOT BEEN UP AND MOVING OR NOT.¿ IT WAS REPORTED THAT THE PATIENT FELT THEY HAD SOME OF THE WARNING SIGNS OF OVERDOSE AND FELT ¿LIGHTHEADED OR DIZZY.¿ IT WAS NOTED THAT THE PATIENT HAD FELT THAT WAY SINCE THEIR REFILL ON (B)(6) 2014. THE PUMP SYSTEM WAS DELIVERING BACLOFEN. 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
    404096 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Other