BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1052987 · Received May 27, 2008

    Report

    Report Number
    6000030-2008-02808
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 24, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED A VOLUME DISCREPANCY GRATER THAN 25%. THE EXPECTED RESERVOIR VOLUME WAS 1.6ML AND THE ACTUAL RESERVOIR VOLUME WAS 18 ML. NO PT SYMPTOMS OR OUTCOME WERE REPORTED. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CATHETER MODEL 8709 LOT# J0058217R| EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNK| EXPLANTED:| IMPLANTED: