BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2161976 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-05314
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 17, 2011
    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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS CUT, SHEARED OR TORN JUST DISTAL TO THE BUTTERFLY ANCHOR, TOWARD THE SPINE. THE ENTIRE CATHETER WAS REPLACED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT WHEN ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention CATHETER: MODEL 8709, LOT# L59319| IMPLANTED:| EXPLANTED: