BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1242958 · Received November 21, 2008

    Report

    Report Number
    6000030-2008-07680
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    August 1, 2008
    Report Date
    October 27, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0956-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER FOR THIS IS WITHIN THE "BEGINNING 1999" POPULATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED WITHDRAWAL SYMPTOMS IN 2008 WHICH REQUIRED A VISIT TO THE EMERGENCY ROOM. A PUMP RESERVOIR VOLUME DISCREPANCY GREATER THAN 25% WAS NOTED AT A RECENT REFILL. THERE WAS MORE VOLUME THAN EXPECTED. THE EXPECTED RESERVOIR VOLUME WAS 2.5 ML; 18 ML WERE WITHDRAWN. NO OTHER VOLUME DISCREPANCIES HAVE BEEN NOTED. THE REPORTER STATED THAT THE MEDICATION DOSAGE WAS INCREASED A COUPLE OF TIMES AND "IT DIDN'T WORK". THE PATIENT WILL UNDERGO A ROTOR DYE STUDY, CATHETER DYE STUDY AND POSSIBLY REPLACEMENT OF PUMP. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, 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 40 YR Required Intervention CATHETER: MODEL 8711| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER