BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 2983356 · Received February 28, 2013

    Report

    Report Number
    6000030-2013-00041
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Report Date
    February 1, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT IN FOR A ROUTINE PUMP REFILL. WHEN WITHDRAWING THE OLD MEDICATION, THE FULL 18 TO 20 CUBIC CENTIMETERS (CC) WERE WITHDRAWN THAT HAD BEEN PLACED LAST TIME. LITTLE TO NO DRUG HAD BEEN DELIVERED SINCE LAST REFILL. THE PATIENT'S SPASMS HAD BEEN WORSE OVER THE PAST MONTH, AND THE PATIENT WAS TIGHTER THAN NORMAL. AN X-RAY WAS GOING TO BE TAKEN OF THE CATHETER TO CHECK FOR ANY ABNORMALITIES. IT WAS NOTED THAT THE PUMP HAD NOT BEEN BEEPING OR GIVING ANY INDICATION THAT THE BATTERY HAD BEEN FAILING. THE PUMP WAS BEING USED TO DELIVER LIORESAL. IT WAS LATER NOTED THAT THE CAUSE OF THE EVENT WAS PUMP BATTERY DEPLETION. A CATHETER DISCONNECTION AT THE PUMP/CATHETER CONNECTION WAS ALSO NOTED TO HAVE BEEN FOUND WHEN DYE RAN THROUGH. IT WAS BELIEVED THAT THE BATTERY FAILED SINCE THEY WITHDREW 18 CC OF MEDICATION WHEN THEY EXPECTED 2 CC. THE PUMP HAD BEEN IMPLANTED APPROXIMATELY 9 YEARS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP WAS REPLACED DUE TO END OF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86637 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627-18

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR