BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 130222 · Received October 30, 1997

    Report

    Report Number
    6000030-1997-00279
    Event Type
    Malfunction
    Date Received
    October 30, 1997
    Date of Event
    September 11, 1997
    Report Date
    September 22, 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

    03/03/1998: H6-PRIMARY FINDING OF DEVICE ANALYSIS REVEALED A MOTOR COIL ANOMALY (OPEN MOTOR COIL) WHICH CAUSED THE PUMP MOTOR TO STALL.

    Description of Event or Problem · 1

    REPORTED AS "STALLED MOTOR" FROM FOREIGN REPORTER

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other