BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 225055 · Received May 21, 1999

    Report

    Report Number
    6000030-1999-00114
    Event Type
    Malfunction
    Date Received
    May 21, 1999
    Date of Event
    March 10, 1999
    Report Date
    March 26, 1999
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A SYNCHROMED PUMP AND CATHETER ON 4/11/1995 TO TREAT NON-MALIGNANT PAIN/FAILED BACK SURGERY SYNDROME. THE PUMP HAS BEEN RETURNED TO THE MFR. THE PT WAS IMPLANTED WITH A MODEL 861718 SYNCHROMED PUMP ON 3/10/1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED Implant IMPLANTABLE INFUSION PUMP LKK MEDTRONIC, INC. 8611H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization 8703W INTRASPINAL CATHETER, IMPLANTED 1995,| STATUS UNK.