BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 129974 · Received October 31, 1997

    Report

    Report Number
    6000030-1997-00282
    Event Type
    Malfunction
    Date Received
    October 31, 1997
    Date of Event
    July 16, 1997
    Report Date
    October 7, 1997
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    03/04/1998: H6- PRIMARY FINDING OF DEVICE ANALYSIS REVEALED NO DEVICE FAILURE, NO ANOMALY FOUND.

    Description of Event or Problem · 1

    REPORT REC'D FROM FOREIGN RPTR AS "PUMP STOPPED AND THERE WAS NO MORE DIFFUSION OF BACLOFEN. APPARENTLY NOT DUE TO THE CATHETER."

    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 * Other