BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2133542 · Received June 15, 2011

    Report

    Report Number
    3004209178-2011-04449
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 18, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S WOUND WAS "OPEN, OOZING AND RED" ABOUT ONE MONTH AFTER IMPLANTATION. THE HCP WAS CONSIDERING CONVERTING THE PT FROM INTRATHECAL TO ORAL BACLOFEN. THE PUMP WAS EXPLANTED DUE TO THE INFECTION, BUT NOT THE CATHETER. THE MEDICATION IN THE PUMP WAS COMPOUNDED BACLOFEN 5000MCG/ML.

    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 34 YR Other| R CATHETER: MODEL 8709, LOT # J0058218R| EXPLANTED:| IMPLANTED: