BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2113770 · Received June 2, 2011

    Report

    Report Number
    3007566237-2011-03933
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 5, 2011
    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

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S PUMP WAS ALARMING EVERY 10 MINUTES. THE LOGS WERE READ, AND THE FIRST MOTOR STALL HAD OCCURRED ON (B)(6) 2011. A MOTOR STALL RECOVERY OCCURRED ON THE (B)(6) 2011. A SECOND MOTOR STALL LATER OCCURRED ON (B)(6) 2011. THE PUMP WAS RE-FILLED ON (B)(6) 2011 AS PER NORMAL TIME FRAMES. THE PT WAS FLOWN TO ADELAIDE; AND THE PUMP WAS REPLACED ON (B)(6) 2011. UPON INTERROGATION ON (B)(6), BOTH A MOTOR STALL AND A "STOPPED PUMP MAY EXCEED TUBE SET" WERE NOTED. THE CATHETER WAS ALSO REPLACED AS IT WAS FOUND TO BE COILED AROUND THE PUMP WITHIN THE PUMP POCKET. THE PT HAD RECOVERED WITHOUT SEQUELA FOLLOWING THE PROCEDURE. THE DRUG ADMINISTERED VIA THE PUMP WAS LIORESAL (2000.0 UG/ML AT 800.7 UG/DAY). ADDITIONAL INFORMATION WILL BE PROVIDED IN A F/U REPORT AS IT 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 Required Intervention CATHETER: MODEL CATHETER, LOT# UNK| EXPLANTED:| IMPLANTED: