BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1490449 · Received July 14, 2009

    Report

    Report Number
    2182207-2009-05619
    Event Type
    Malfunction
    Date Received
    July 14, 2009
    Date of Event
    April 13, 2006
    Report Date
    April 13, 2006
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004/S56
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AS A RESULT OF A REVIEW OF OUR MDR PROCEDURE WITH FDA IT WAS DETERMINED THAT EVENTS IN CLINICAL STUDIES SHOULD HAVE BEEN REPORTED WITHIN A 30-DAY TIME FRAME. WE ARE FILING THESE LATE REPORTS AS DIRECTED BY THE STAFF. IT WAS REPORTED THAT FOLLOW-UP VISITS IN 2006, THE PATIENT'S DAILY DOSE WAS INCREASED. AT THE VISIT IN 2006, THERE WAS A REFILL VOLUME DISCREPANCY; 33.2 ML WERE IN THE PUMP. AT ONE OF THE VISITS AFTERWARD (UNSPECIFIED WHICH) THE REFILL VOLUME WAS IN RANGE. THE CATHETER HAD BEEN REPLACED IN 2006, (SEE MANUFACTURER REPORT 6000030-2007-00519). THERE WAS NO APPARENT ADVERSE EVENT ASSOCIATED WITH THE REFILL DISCREPANCY.

    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 23 YR PROGRAMMER: MODEL 8840, LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8731, LOT# N005394506| IMPLANTED:| CATHETER: MODEL 8731, LOT# N003299305