BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2972995 · Received February 21, 2013

    Report

    Report Number
    3004209178-2013-02967
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    January 31, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: PRODUCT ID 8711, LOT# J10891R28, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS OF THE PUMP REVEALED MOTOR CORROSION, WEAR, AND/OR LUBRICATION AS WELL AS A GEAR TRAIN ANOMALY. THE PUMP PASSED ALL NON -DESTRUCTIVE LAB TESTING. DURING DESTRUCTIVE ANALYSIS, SIGNIFICANT RESISTANCE WHEN TRYING TO MANUALLY TURN GEAR THREE WAS OBSERVED. SIGNIFICANT RESIDUE ON GEAR THREE'S O-RING WAS ALSO LOCATED ON THE TOP BRIDGE. RESIDUE WAS OBSERVED ON THE PINION OF GEAR TWO AND THE UPPER SHAFT OF GEAR THREE. ANALYSIS OF THE CATHETER REVEALED THE CATHETER WAS INCOMPLETE AND RETURNED IN SEGMENTS. THE CATHETER PASSED ACCEPTABLE TESTING.

    Description of Event or Problem · 1

    NO INFORMATION WAS REPORTED WITH THE RETURNED PRODUCT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76734 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1