BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED

    MDR report key: 115549 · Received August 22, 1997

    Report

    Report Number
    2182207-1997-00224
    Event Type
    Malfunction
    Date Received
    August 22, 1997
    Date of Event
    July 17, 1997
    Report Date
    July 22, 1997
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    02/03/1998: H6-PRIMARY FINDING OF DEVICE ANALYSIS REVEALED MOTOR STALL DUE TO BROKEN MOTOR GEAR.

    Description of Event or Problem · 1

    REPORTED AS "PUMP ROTOR NEVER RESTARTED AFTER PLACED ON 'STOPPED PUMP' MODE. STOPPED PUMP MODE WAS FOR APPROX. 14 HOURS.

    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 31 YR Other MODEL 8703W CATHETER, LOT #L36764