BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 129809 · Received October 29, 1997

    Report

    Report Number
    6000030-1997-00276
    Event Type
    Malfunction
    Date Received
    October 29, 1997
    Date of Event
    August 26, 1997
    Report Date
    September 9, 1997
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    03/04/1998: H6- PRIMARY FINDING OF DEVICE ANALYSIS REVEALED STALL DUE TO BATTERY DEPLETION/END OF LIFE. THERE WAS ALSO EVIDENCE OF MOTOR GEAR SHAFT ON ALL GEARS.

    Description of Event or Problem · 1

    REPORTED AS "STALLED ROTOR" FROM FOREIGN REPORTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other