BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1190359 · Received October 6, 2008

    Report

    Report Number
    2182207-2008-06361
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 9, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE PUMP REFILL. THE PATIENT REPORTED THAT THE PUMP WAS ALARMING. THE PUMP WAS INTERROGATED AND A "MOTOR STALL OCCURRED. STOPPED PUMP PERIOD MAY EXCEED TUBE SET" MESSAGE WAS NOTED. THE NURSE REFILLED THE PUMP AND REPROGRAMMED. IT WAS NOTED THAT THE RESERVOIR VOLUME WAS 18ML GREATER THAN WAS EXPECTED (THE EXPECTED RESERVOIR VOLUME WAS NOTED NOT REPORTED). THE PUMP WAS INTERROGATED 30 MINUTES AFTER REFILL AND THE MOTOR STALL ALARM HAD RECURRED. THE PATIENT'S PUMP WAS REPLACED. THE PATIENT RECOVERED WITHOUT SEQUELA. THE DRUG CONTAINED IN THE PATIENT'S PUMP WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention PROGRAMMER MODEL 8840 LOT #UNKNOWN| EXPLANTED| CATHETER MODEL CATHETER LOT# UNKNOWN IMPALNTED