BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2053607 · Received March 1, 2011

    Report

    Report Number
    3007566237-2011-01521
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    October 1, 2010
    Report Date
    February 14, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD SEVERAL MOTOR STALLS STARTING IN (B)(6) 2010 WITH RECOVERIES NOTED IN THE EVENT LOGS. THE PUMP WAS ALARMING. THE PT MAY HAVE HAD X-RAYS AND DID GO THROUGH A FULL BODY SCANNER. A MOTOR STALL OCCURRED ON (B)(6) 2011 AT 1653 AND DID NOT RECOVER. THE PUMP HAD AN ERI (ELECTIVE REPLACEMENT INDICATOR) OF 26 MONTHS. THE PT WAS BEING "SUPPLEMENTED WITH ORALS". THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS COMPOUNDED MORPHINE. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 60 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# N04778026