BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 3201648 · Received July 2, 2013

    Report

    Report Number
    6000030-2013-00020
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    January 1, 2011
    Report Date
    February 24, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HAVING SEVERE LOWER STOMACH PAIN OFF AND ON FOR THE PAST TWO AND A HALF YEARS. THE PAIN HAD BEEN CONSTANT FOR THE PAST FEW MONTHS. THE PAIN WAS LOCATED BELOW THE PATIENT¿S BELLY BUTTON, AND SOMETIMES OCCURRED AROUND THE PUMP. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID. THE PUMP WAS LAST FILLED WITH MEDICATION IN (B)(6) OF 2011. THE PATIENT THEN HAD SALINE IN THE PUMP. IT WAS REPORTED THAT THE PUMP NEVER WORKED AND IT NEVER ¿DID THE PATIENT ANY GOOD.¿ ON (B)(6) 2012, THE PATIENT HAD THEIR PUMP FILLED WITH HYDROMORPHONE AND BUPIVACAINE. 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
    303408 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR