BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3213198 · Received July 9, 2013

    Report

    Report Number
    3004209178-2013-11485
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 17, 2013
    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
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8590-1, LOT# N286615, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP HAD BEEN FLIPPING AND WAS PREVIOUSLY REVISED DUE TO THE PUMP FLIPPING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. FOR SUBSEQUENT EVENTS SEE MANUFACTURER¿S REPORT # 3004209178-2013-11472.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311969 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention