BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1980363 · Received February 3, 2011

    Report

    Report Number
    3004209178-2011-00847
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    January 18, 2011
    Report Date
    April 28, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A "CATHETER DEVIATION" WAS OBSERVED IN X-RAY EVAL. THE DISTAL CATHETER WAS REPLACED ON (B)(6) 2011. THE PT RECOVERED. THE DEVICE SYSTEM WAS USED TO DELIVER GABALON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Required Intervention "SEE H10...."| CATHETER: MODEL 8711, LOT# N248513003.| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT# N248513003| IMPLANTED:| EXPLANTED: