BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHORMED

    MDR report key: 298685 · Received September 27, 2000

    Report

    Report Number
    6000030-2000-00262
    Event Type
    Malfunction
    Date Received
    September 27, 2000
    Date of Event
    July 5, 2000
    Report Date
    July 13, 2000
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFO PROVIDED TO MFR VIA DEVICE RETURN FORM. "PUMP WAS STOPPED FOR A FEW WEEKS. AFTER RESTARTING THE PUMP, THE PT'S PAIN WAS NOT CONTROLLED. AT THE SECOND REFILL THERE WERE 18 CC OF DRUG STILL IN PUMP - PROGRAMMED PURGE BOLUS IN OPERATING ROOM - NO DROPLET FORMED AT THE TIP." SUSPECT PUMP FAILURE - ROTOR STALL. PUMP REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHORMED IMPLANTABLE INFUSION PUMP LKK MEDTRONIC, INC. 861618 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization CATHETER MODEL 8703W LOT # L43277 IMPLANTED 1997| EXPLANTED 2000.