BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3133939 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08310
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 2, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8590-1, N206955, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN SPASTICITY. A LEAK PRESSURE TEST WAS PERFORMED AND IT WAS NOTED THAT THERE WERE ¿PIN HOLES¿ IN THE PROXIMAL AND DISTAL SEGMENTS OF THE CATHETER. THE PROXIMAL AND DISTAL SEGMENTS OF THE CATHETER WERE REPLACED ON (B)(6) 2013. THE PATIENT¿S STATUS WAS REPORTED AS "ALIVE - NO INJURY/NO ADVERSE EVENT" AT THE TIME OF THE REPORT. THE PUMP WAS BEING USED TO DELIVER BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235294 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Required Intervention