BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3233196 · Received July 18, 2013

    Report

    Report Number
    6000030-2013-00187
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 24, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, EXPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER (HCP) REPORTED THAT THE EVENT ¿DID NOT HAPPEN¿.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S LAST PUMP WAS COMPLETELY ¿PLUGGED¿ WHEN THE HEALTH CARE PROVIDER REPLACED IT AND THE PATIENT WAS NOT GETTING ANY MEDICATION. IT WAS STATED ¿AND HE SAID IT COULDN¿T NOTICE ANY DIFFERENCE. AND HE SAID IT¿S GOT TO BE GOING SOMEWHERE.¿ THE MEDICATION WAS REPORTEDLY NOT GOING INTO THE CATHETER BUT IT WAS NOT STAYING IN THE PUMP EITHER. IT WAS LEAKING ¿AROUND MAYBE AROUND IT OR SOMETHING BECAUSE HE SAID WHEN HE WOULD GO TO REFILL IT THE DOCTOR COULDN¿T EVEN TELL THAT THE PUMP WASN¿T.¿ AT THE TIME OF THE REPLACEMENT, THE DEVICE SYSTEM HAD BEEN USED TO DELIVER HYDROMORPHONE HOWEVER IT WAS ALSO NOTED THE HEALTH CARE PROVIDER HAD ¿THEIR OWN LITTLE MIXTURE IN THERE.¿ 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
    336277 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627-18

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Required Intervention