BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3240783 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12091
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 27, 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 Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SYMPTOMS AND THERE WAS A VOLUME DISCREPANCY. THE PUMP WAS REFILLED THE DAY PRIOR AND AT THAT TIME THERE WAS AN EXPECTED RESIDUAL VOLUME OF 2ML AND ACTUAL RESIDUAL VOLUME ASPIRATED WAS OVER 10ML. THE PATIENT RETURNED TO THE HEALTH CARE PROVIDER (HCP) THE DAY OF REPORT WITH SEVERE SPASTICITY CHANGES, WITHDRAWAL CLONUS AND PRURITUS. THE HCP CHECKED THE RESERVOIR ON THE DAY OF REPORT AND THE PUMP WAS FULL FROM THE PREVIOUS DAY¿S REFILL,SO IT WAS CONFIRMED THERE WAS NOT A MISS FILL. IT WAS NOTED THE HCP HAD PROGRAMMED A DOSE DECREASE AT REFILL TO 1138 MCG/DAY, SO THE HCP PROGRAMMED THE PATIENT BACK TO 1200 MCG/DAY ON DAY OF REPORT. THE HCP WAS STATED ¿I DON¿T KNOW WHY HE SUDDENLY WENT INTO WITHDRAWAL¿. THERE WERE NO ISSUES NOTED IN THE PUMP LOGS. THE HCP PLANNED TO DO FURTHER TROUBLESHOOTING. THE PUMP DEVICE WAS USED TO DELIVER GABLOFEN. 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
    340508 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Other