BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1082480 · Received July 25, 2008

    Report

    Report Number
    2182207-2008-04410
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT PUMP REFILL A VOLUME DISCREPANCY GREATER THAN 25% WAS NOTED. THE EXPECTED RESERVOIR VOLUME WAS 3.6 ML WHILE THE ACTUAL RESERVOIR VOLUME WAS 40 ML; THE PUMP IS A 20 ML PUMP. THE PATIENT LATER PRESENTED TO THE EMERGENCY ROOM WITH THE FOLLOWING SYMPTOMS: HEADACHE, SWELLING AROUND THE PUMP, LETHARGY, VOMITING AND ASPIRATION. THE PATIENT REPORTED TO THE HCP THAT AT REFILL, THEY THOUGHT THAT THEY HAD ASPIRATED 20 ML OF CEREBROSPINAL FLUID AND 20 ML OF DRUG. THE RESERVOIR WAS AGAIN ACCESSED AND 3 ML WERE ASPIRATED; A POCKET FILL WAS SUSPECTED. THE PUMP WAS SET TO MINIMUM RATE AT THAT POINT. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE INTENSIVE CARE UNIT FOR MONITORING. THE PATIENT WAS "DOING BETTER". THE HCP LATER REPORTED FILLING OR ASPIRATING THE RESERVOIR. A DYE STUDY WAS DONE AND THE CATHETER WAS PATENT. THE PUMP WAS THEN FILLED SUCCESSFULLY. 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 II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNKNOWN| CATHETER MODEL 8709 LOT# J0039909R| EXPLANTED: