BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1023481 · Received April 2, 2008

    Report

    Report Number
    2182207-2008-01733
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    February 13, 2008
    Report Date
    March 3, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MOTOR STALL WAS CONFIRMED IN PUMP EVENT LOGS. THE PT HAD AN MRI AND DID NOT HAVE THE PUMP STATUS CHECKED POST MRI. TWENTY DAYS LATER, UPON INTERROGATION OF THE PUMP THE MOTOR STALL WAS NOTICED, A 'STOPPED PUMP PERIOD MAY EXCEED TUBE SET' MESSAGE WAS ALSO SEEN. THE MOTOR STALL RECOVERY OCCURRED DURING THIS INTERROGATION. NO AUDIBLE ALARMING WERE OCCURRING AND NO PT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED; THE MFR'S DEVICE REGISTRATION SYSTEM INDICATES IT IS DILAUDID. 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 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR CATHETER MODEL 8709 LOT# J0039928R| EXPLANTED| IMPLANTED| IMPLANTED| EXPLANTED| PROGRAMMER MODEL 8840 LOT# UNK