BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3201556 · Received July 2, 2013

    Report

    Report Number
    6000030-2013-00073
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    January 4, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8711, LOT# J11509R55, IMPLANTED: (B)(6) 2003. PRODUCT TYPE: CATHETER: PRODUCT ID 8711, LOT# J11414R08, IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2003. PRODUCT TYPE: CATHETER: PRODUCT ID 8711, LOT# J11414R01, IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2003. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DRUG WITHDRAWALS. THE PATIENT HAD TO TAKE ORAL MEDICATION. THE CATHETER HAD DISCONNECTED FROM THE PUMP AND THE PUMP WAS DISPENSING MEDICATION INTO THE PATIENT¿S BODY. THIS CAUSED THERAPY TO STOP, BUT IT TOOK A WHILE FOR THE PATIENT TO START FEELING THE EFFECTS OF WITHDRAWAL. THE PUMP WAS READ AND WAS RUNNING FINE. THE DISCONNECTION HAPPENED THREE TIMES. THE PATIENT HAD TO ¿HAVE IT FIXED¿ TWICE. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303480 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627-18

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention