BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 808291 · Received June 8, 2006

    Report

    Report Number
    6000030-2006-00940
    Event Type
    Malfunction
    Date Received
    June 8, 2006
    Date of Event
    May 30, 2006
    Report Date
    May 30, 2006
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HCP REPORTED THAT PUMP RESERVOIR VOLUME WAS 18 ML INSTEAD OF EXPECTED 3.9 ML AT REFILL. THE PT BLACKED OUT AND BLOOD PRESSURE INCREASED TO 190/100 AFTER REFILL. THE PT SAT DOWN AND FELT BETTER. HCP STATED THE REFILL WAS DONE INTO THE PUMP RESERVOIR AND THEY WERE USING THE PROPER REFILL KIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention IMPLANTED| CATHETER MODEL 8703 LOT# J93117895| EXPLANTED