BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3193243 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-10972
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PUMP AND CATHETER WERE EXPLANTED AND REPLACED ON (B)(6) 2013 DUE TO INFECTION/MENINGITIS. THE LOCATION OF THE INFECTION/MENINGITIS WAS THE DEVICE POCKET AND CATHETER TRACK. IT WAS NOTED THAT MEDICAL INTERVENTION WAS REQUIRED; HOWEVER, WAS NOT SPECIFIED. PATIENT OUTCOME WAS REPORTED AS NO INJURY OR ADVERSE EVENT. THE DEVICE SYSTEM DELIVERED GABLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292464 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention