BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1823432 · Received August 25, 2010

    Report

    Report Number
    6000030-2010-06455
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    January 1, 2009
    Report Date
    July 28, 2010
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS NOT RECEIVING EFFICACY FROM THEIR DRUG/PUMP. AN ISOTOPE PUMP STUDY REVEALED THAT THERE WAS NO DRUG FOUND IN THE SUBARACHNOID SPACE. AN X-RAY WAS CONDUCTED. AS TESTED ON (B)(6) 2009, THERE WAS NO EVIDENCE OF PERIPUMP RADIONUCLIDE ACTIVITY. NO FREE FLOW OF CSF WAS SEEN ON (B)(6) 2009. THE PUMP WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. THE MOST RECENT DRUG INFO REPORTED WAS SIMPLE CONTINUOUS INFUSION OF BACLOFEN (250 MCG/ML, 26.4 MCG/DAY) ADMINISTERED ON (B)(6) 2009. THE PT HAD RECOVERED WITHOUT SEQUELA. ADDITIONAL INFO 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
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention CATHETER: MODEL 8731, LOT # B003308N55| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8731, LOT # B003308N55| EXPLANTED: