BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 129768 · Received October 29, 1997

    Report

    Report Number
    6000030-1997-00275
    Event Type
    Malfunction
    Date Received
    October 29, 1997
    Date of Event
    August 18, 1997
    Report Date
    September 2, 1997
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Removal / Correction Number
    Z-152/156-7
    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 INTERMITTENT STALLING DUE TO MOTOR COIL ANOMALY/OPEN MOTOR COIL.

    Description of Event or Problem · 1

    REPORTED AS "PUMP ROTOR STALLED" FROM FOREIGN REPORTER.

    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 * Other