BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 127300 · Received October 17, 1997

    Report

    Report Number
    6000030-1997-00263
    Event Type
    Malfunction
    Date Received
    October 17, 1997
    Date of Event
    September 12, 1997
    Report Date
    September 18, 1997
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    03/04/1998: H6- PRIMARY FINDING OF DEVICE ANALYSIS REVEALED MOTOR STALL DUE TO MOTOR GEAR CORROSION.

    Description of Event or Problem · 1

    REPORTED AS "WHEN THE PUMP WAS EXAMINED UNDER FLUOROSCOPY, THE MOTOR WAS HARDLY MOVING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED Implant IMPLANTABLE INFUSION PUMP LKK MEDTRONIC, INC. 8615LS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| O MODEL 8703W CATHETER, LOT #L38431, IMPLANTED