BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201496 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-04819
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    March 1, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS CURRENTLY HOSPITALIZED AND HAD AN MRI THE MORNING OF THE REPORT. THE PUMP HAD NOT YET BEEN INTERROGATED TO DETERMINE OF MOTOR STALL/MOTOR STALL RECOVERY HAD OCCURRED. THE REASON FOR THE HOSPITALIZATION WAS UNKNOWN. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303289 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Hospitalization