BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2434684 · Received February 1, 2012

    Report

    Report Number
    3004209178-2012-00615
    Event Type
    Injury
    Date Received
    February 1, 2012
    Date of Event
    November 17, 2011
    Report Date
    January 8, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8596SC, SERIAL #: (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: UNK; CATHETER MODEL (PROXIMAL REV KIT SEG): 8596, SERIAL #: (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: UNK; CATHETER MODEL (DISTAL REV KIT SEG): 8598, SERIAL #: (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: UNK.

    Description of Event or Problem · 1

    AN INFECTION AFTER PUMP REPLACEMENT ON (B)(6) 2011 WAS REPORTED. SIGNS/SYMPTOMS INCLUDED PURULENT DISCHARGE FROM ABDOMINAL WOUND. IT RESULTED IN IN-PATIENT HOSPITALIZATION. THE ENTIRE SYSTEM WAS EXPLANTED; POSSIBLY RELATED TO THE DEVICE OR THERAPY/RELATED TO IMPLANT PROCEDURE. PATIENT OUTCOME WAS NOTED AS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2012. IT WAS LATER REPORTED THAT THE DEVICE SYSTEM WAS DISPOSED OF ACCORDING TO BIOHAZARD INSTRUCTIONS. PATIENT WAS USING "GABLOFEN BACLOFEN"; PUMP LOGS SHOWED BOTH BACLOFEN AND GABLOFEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR