BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3851776 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-10204
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 10, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER; PRODUCT ID 8575, LOT# J0212458R, IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED DUE TO AN INFECTION. THE DRUG IN THE PUMP WAS BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328510 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00020 YR Required Intervention