BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 215342 · Received March 17, 1999

    Report

    Report Number
    6000030-1999-00070
    Event Type
    Malfunction
    Date Received
    March 17, 1999
    Date of Event
    January 21, 1999
    Report Date
    February 17, 1999
    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

    PATIENT WAS IMPLANTED WITH A SYNCHROMED PUMP AND CATHETER ON 6/10/1996 FOR DELIVERY OF MORPHINE TO TREAT NONMALIGNANT PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME. ON 01/21/1999 THE DEVICE WAS EXPLANTED AFTER THE PATIENT EXPERIENCED INCREASED PAIN AND AN X-RAY REVEALED THE MOTOR'S ROTOR WAS NOT MOVING. ANOTHER SYNCHROMED PUMP WAS IMPLANTED AND THE PATIENT HAD IMPROVED PAIN RELIEF DURING HIS 02/20/1999 PUMP REFILL VISIT WITH HIS HEALTH CARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED Implant IMPLANTABLE INFUSION PUMP LKK MEDTRONIC, INC. 861718 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization 8703W INTRATHECAL CATHETER IMPLANTED 06/10/1996,| STATUS UNKNOWN.