BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2223875 · Received August 18, 2011

    Report

    Report Number
    3007566237-2011-06550
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 1, 2011
    Report Date
    January 17, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED NO SIGNIFICANT ANOMALIES. THE PUMP HAD REACHED EOS DUE TO TIME PROGRESSION. A 2-TONE ALARM WAS HEARD. THE PUMP WAS PROGRAMMED TO OFF STATE.

    Description of Event or Problem · 1

    THE PT WAS ADMITTED TO THE HOSPITAL DUE TO THE PUMP REACHING EOS (END OF SERVICE). THE PT WAS BELIEVED TO BE IN WITHDRAWAL DUE TO THE PUMP HAVING STOPPED. PER THE PUMP LOGS FROM (B)(6) 2011, IT WAS NOTED THAT ERI (ELECTIVE REPLACEMENT INDICATOR) OCCURRED (B)(6) 2011 AND STATED "SCHEDULE TO REPLACE THE PUMP BY (B)(6) 2011." EOS OCCURRED ON (B)(6) 2011. ON (B)(6) 2011, THE STOPPED PUMP PERIOD MAY EXCEED TUBE SET MESSAGE OCCURRED. THE LOGS ALSO NOTED A "TERMINAL EVENT HAS OCCURRED IN THE PUMP." THE PT DID HAVE A SCHEDULED APPOINTMENT TO SEE THE HCP IN CONSULTATION FOR A PUMP REPLACEMENT, BUT DID NOT REALIZE THE APPOINTMENT WAS SCHEDULED TO OCCUR AFTER THE PUMP'S "HARD STOP" DATE. IT WAS BELIEVED THE DATE LISTED AS THE STOP DATE WAS THE DATE WHICH STARTED THE "90 DAYS UNTIL STOP" INTERVAL. THEREFORE, THE PUMP STOPPED AND THE PT EXPERIENCED WITHDRAWAL. THE PT'S MOTHER NEVER HEARD THE PUMP ALARM. PER THE REPORTER, AN AUDIBLE PUMP ALARM WAS CLEARLY SOUNDING WHEN THE PUMP WAS EXPLANTED ON (B)(6) 2011, AND THE LOGS SHOWED THE PUMP HAD BEEN ALARMING. THE ALARMS WERE THEN SILENCED/STOPPED. SINCE THE PUMP WAS REPLACED, THE PT HAS RETURNED TO DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| R IMPLANTED:| CATHETER: MODEL 8596SC, LOT# N291049001| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J53385R13