BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3203136 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04582
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    October 18, 2012
    Report Date
    October 18, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THERE WAS A MOTOR STALL AND MOTOR STALL RECOVERY CAUSED BY HAVING A MAGNETIC RESONANCE IMAGING (MRI) PROCEDURE OR OTHER MEDICAL PROCEDURE. THE ISSUE HAD BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302312 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1