BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1950059 · Received December 7, 2010

    Report

    Report Number
    3007566237-2010-10266
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 30, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PUMP TELEMETRY CONFIRMED AN ALARM DUE TO A MOTOR STALL. THE EVENT LOGS INDICATED A MOTOR STALL WHICH OCCURRED AT 2333 ON (B)(6) 2010. THE PT DID NOT HAVE AN MRI. THE PT WAS WELDING THE DAY BEFORE THE MOTOR STALL, BUT THE TIMES AND DATES DO NOT MATCH UP AS A POSSIBLE REASON FOR STALL. THE PT HAD EXPERIENCED UNDERDOSE SYMPTOMS AND WAS BEING MONITORED BY THEIR PHYSICIAN WHILE ON INTRAVENOUS FENTANYL THERAPY. THE PUMP WAS TO BE PROGRAMMED AT THE MINIMUM RATE WHILE THE PT WAS ON IV THERAPY IN ORDER TO AVOID AN OVERDOSING ISSUE. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE BUPIVICAINE, CLONIDINE, AND SUFENTANIL.

    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 55 YR IMPLANTED:| CATHETER: MODEL 8709, LOT# J12040R04| EXPLANTED: