BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1242952 · Received November 21, 2008

    Report

    Report Number
    2182207-2008-07665
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 25, 2008
    Report Date
    October 27, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CRITICAL ALARM INDICATING THAT THE PUMP MOTOR WAS INTERMITTENTLY STALLING. THIS WAS CONFIRMED IN THE EVENT LOGS. THE PATIENT HAS HAD THREE MOTOR STALLS. THE FIRST TONE RECOVERED AFTER ABOUT 30 MINUTES. THE SECOND STALL OCCURRED IN 2008, EVENT LOGS INDICATED "STOPPED PUMP PERIOD MAY EXCEED TUBE SET". THIS STALL THEN RECOVERED THREE DAYS LATER, AT 1123. THE MOST RECENT STALL OCCURRED ON THE SAME DAY, AT 1545 WITH NO RECOVERY RECORDED IN THE EVENT LOGS. THE REPORT INDICATED THAT THERE WAS NO MAGNETIC INTERFERENCE WITH ANY OF THE PUMP MOTOR STALLS. THE PATIENT EXPERIENCED INCREASED BASELINE PAIN, WEAKNESS AND LETHARGY. ACCORDING TO THE MANUFACTURER'S DEVICE TRACKING SYSTEM THE PUMP WAS REPLACED. THE PUMP WAS USED TO DELIVER MORPHINE SULFATE, CONCENTRATION AND DOSAGES WERE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 63 YR Hospitalization| R EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8709| PROGRAMMER: MODEL 8840| CATHETER: MODEL 8709| EXPLANTED:| LOT# NGH045037R| IMPLANTABLE INFUSION PUMP: MODEL 8627L18