BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1837228 · Received September 7, 2010

    Report

    Report Number
    3007566237-2010-06839
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 10, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A PUMP MEMORY ERROR (PME). IT WAS NOTED PUMP INFUSION MODE WAS PROGRAMMED TO MINIMUM RATE AND THAT ERROR DID NOT OCCUR DURING AN UPDATE OR INTERROGATION. TELEMETRY DID NOT REPORT THAT PUMP MEMORY ALARM OCCURED. THE LOGS INDICATED WATCHDOG, RESET OCCURED, AND PUMP WAS IN SAFE STATE. PROGRAMMING WAS ALL WIPED OUT EXCEPT FOR PUMP SERIAL NUMBER AND MODEL NUMBER. THE PUMP TRIED TO BE UPDATED SEVERAL TIMES, BUT EVERY UPDATE WAS UNSUCCESSFUL AND RESULTED IN PME MESSAGE. A THERAPY STOP WAS ATTEMPTED. THE FIRST TIME TELEMETRY STOPPED HALF WAY AND THE SECOND TIME IT WAS CANCELLED BY THE PROGRAMMER AND DISPLAYED A MESSAGE "THE TELEMETRY WAS ABORTED AND THE PUMP CAN NOT DETERMINE THE LAST VERSION, VERSION IN THIS PROGRAMMER IS B.4 RECORD THIS INFORMATION." THE MESSAGE ALSO APPEARED DURING AN UPDATE. THE PUMP WAS ALSO ATTEMPTED TO BE UPDATE IN MINIMUM RATE MODE, BUT STILL PME. IT WAS ATTEMPTED TO UPDATE THE PUMP OVER 10 TIMES AND TRIED USING A DIFFERENT PROGRAMMER. THERE WERE NO PME IN LOGS. IT WAS NOTED PATIENT WAS IN 5MG/ML BUPIVICAINE. IT WAS ALSO REPORTED ALARM WAS HEARD BUT NOT CONFIRMED BY TELEMETRY. IT WAS NOTED PATIENT STATED AN ERROR CODE "8474" SHOWED ON THEIR PATIENT MONITOR (PTM), WHICH INDICATED A CRITICAL PUMP ALARM FOR "PUMP RESET." IT WAS NOTED PATIENT SHOWED NO ADVERSE EFFECTS. THERE WAS NO KNOWN CAUSE FOR THE PME. PUMP WAS INTERROGATED MULTIPLE TIMES AND PUMP WOULD NOT RECEIVE TELEMETRY. PUMP WAS EXPLANTED AND PATIENT RECEIVED NEW PUMP. PATIENT RECOVERED WITHOUT SEQUELA. ADDITIONAL INFORMATION WILL BE PROVIDED WHEN AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention