BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3143394 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08574
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 7, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT SOME POINT THIS YEAR WHILE THE PATIENT WAS DRIVING SHE EXPERIENCED A SEIZURE AND ¿TOTALED OUT¿ HER CAR. REPORTEDLY, THEY ¿ASSUMED¿ THE PATIENT HAD A SEIZURE BECAUSE THERE WAS NO OTHER SIGN OF ANY OTHER ACCIDENT. THE PATIENT STATED SHE DID NOT KNOW IF ¿I WAS AVOIDING WILDLIFE BECAUSE I WAS TOTALLY KNOCKED OUT.¿ THE PATIENT ¿WOKE UP¿ AND WAS IN THE HOSPITAL.¿ THIS PATIENT¿S PUMP WAS REFILLED EVERY THREE MONTHS AND THE PATIENT WAS REQUIRED TO TRAVEL 45 MINUTES ONE WAY TO GET IT REFILLED. HER NEXT REFILL IS (B)(6) 2013. THIS DEVICE SYSTEM DELIVERED 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
    243915 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O