BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3802578 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08798
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED SYMPTOMS OF INFECTION AND AN EXPLANT WAS PLANNED. IT WAS ALSO NOTED THE PATIENT WAS HOSPITALIZED. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS NOTED AS ALIVE, WITH INJURY. ADDITIONAL INFORMATION LATER REPORTED THE PATIENT NOTICED REDNESS AND OOZING COMING OUT OF POCKET. THE CULTURE SHOWED PSEUDOMONAS AND THE PATIENT WOULD RECEIVE IV ANTIBIOTICS FOR 10 DAYS. THE PUMP WAS USED TO DELIVER FENTANYL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS DOING WELL POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281678 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R