BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1892264 · Received November 2, 2010

    Report

    Report Number
    6000030-2010-08743
    Event Type
    Injury
    Date Received
    November 2, 2010
    Report Date
    October 7, 2010
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT NEVER HAD THERAPEUTIC EFFECT. THE PT SUGGESTED THAT THE ACTUAL RESIDUAL PUMP VOLUME WAS GREATER THAN THE EXPECTED RESIDUAL PUMP VOLUME. THE PT STATED THAT A STROKE, DIABETES, A "BACK CAVE IN," AND INTERNAL BLEEDING WERE EXPERIENCED AND BELIEVED THAT ALL WERE ATTRIBUTABLE TO THE PRESENCE OF THE PUMP. THE PT ALSO REPORTED A "PAINFUL JABBING" OF THE PUMP INTO THE PT'S INTERNAL ORGANS, AND THAT THE PUMP "ATE THE CARTILAGE". THE PUMP HAD NOT BEEN TURNED ON OR FILLED FOR THE PREVIOUS THREE TO FOUR YEARS. THE PT REQUESTED THE REMOVAL OF THE PUMP .THERE WAS NO INFO PROVIDED REGARDING THE TYPE, CONCENTRATION OR DOSAGE OF MEDICATION USED IN THE PT'S PUMP. NO FURTHER DETAILS OR PT OUTCOME WERE PROVIDED. ADD'L INFO WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other IMPLANTED:| CATHETER: MODEL 8709, LOT# J0056614R| EXPLANTED: