BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3142995 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08552
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A RECENT PUMP IMPLANT, THERE WAS SOME REDNESS AT THE PUMP SITE. THE PATIENT'S HEALTHCARE PROVIDER (HCP) BELIEVED THE PATIENT MAY HAVE A POSSIBLE ¿PUMP INFECTION OR A LITTLE WOUND ISSUE¿. SALINE WAS IN PUMP AND THE (HCP) DECIDED TO WAIT TO MAKE SURE INFECTION/ISSUE WOULD BE CLEAR BEFORE FILLING THE PUMP. IT WAS REPORTED THE PATIENT WOULD BE SEEING A NEUROSURGEON TO CONSULT ABOUT THE POSSIBLE INFECTION THEY SAW. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244893 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Other