BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1715120 · Received June 8, 2010

    Report

    Report Number
    3004209178-2010-04604
    Event Type
    Injury
    Date Received
    June 8, 2010
    Date of Event
    May 6, 2010
    Report Date
    May 11, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A LACERATION TO HIS BACK DUE TO A FALL ONTO A SPRINKLER HEAD. THIS REOPENED HIS PRIOR LUMBAR INCISION AND THE CATHETER WAS EXPOSED. THE PT EXPERIENCED INCREASED PAIN. THE CATHETER WAS EXPLANTED. THE PT WAS GIVEN OXYCONTIN (20 MG Q 8 HRS) AND NORCO (10/325) Q 3 HRS PRN. THE DEVICE SYSTEM WAS USED TO DELIVER HYDROMORPHONE AND BUPIVICAINE. ON (B) (6) 2010, UNSPECIFIED MEDICATION ADJUSTMENT WAS MADE. THE PT RECOVERED WITH SEQUELA OF INCREASED PAIN; "ONGOING EVENT".

    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 59 YR Required Intervention CATHETER: MODEL 8709SC, LOT # N244195004| IMPLANTED:| EXPLANTED: