BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 3203557 · Received July 3, 2013

    Report

    Report Number
    6000030-2013-00088
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    August 14, 2012
    Manufacturer
    RICE CREEK
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# J10925R52, IMPLANTED: (B)(6) 2002. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    ONE REPORTER SAID THAT THE HEALTH CARE PROVIDER (HCP) COULD NOT PULL MEDICATION OUT OF THE PUMP, BOTH THIS PUMP AND THE NEW REPLACEMENT PUMP (SEE MANUFACTURER¿S REPORT # 3004209178-2012-07866 REGARDING THE NEW PUMP). THE REPORTER SAID IT HAD BEEN LIKE THAT EVER SINCE THE PATIENT HAD THE PUMP, AND THE REPORTER FELT THAT THE PHYSICIAN WAS NOT ¿DOING ANYTHING ABOUT THAT¿. ADDITIONAL INFORMATION RECEIVED INCLUDED THAT THE CAUSE OF THE EVENT OF PREMATURE BATTERY DEPLETION OF THE PUMP. HOWEVER, DEVICE IMPLANT RECORDS INDICATED THAT THE PUMP HAD BEEN IMPLANTED FOR 106.1 MONTHS. IT WAS REPORTED THAT THE PUMP WAS REPLACED AND IT WAS UNKNOWN IF THE PUMP WOULD BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. IT WAS REPORTED THAT THE PATIENT DID REQUIRE HOSPITALIZATION FOR THE EVENT BUT THE PATIENT¿S OUTCOME WAS REPORTED AS NO INJURY. IT WAS REPORTED THAT THE DRUG BEING USED IN THE PUMP WAS FENTANYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304795 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R