BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2922600 · Received January 18, 2013

    Report

    Report Number
    3004209178-2013-00760
    Event Type
    Injury
    Date Received
    January 18, 2013
    Report Date
    January 3, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8784 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID, 8782 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL REPORTED INFORMATION INDICATED THAT THE PATIENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2012. THE DEVICE SYSTEM WAS USED TO DELIVER SUFENTA, BUPIVACAINE AND CLONIDINE

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LUMBAR WOUND DEHISCENCE OCCURRED. THE DIAGNOSTIC METHODS WERE EXAMINATION/PALPATION AND THE RESULTS WERE AN OPEN LUMBER WOUND SITE. IT WAS REPORTED THAT BOTH CATHETERS WERE EXPLANTED AND WERE DISPOSED OF ACCORDING TO BIOHAZARD INSTRUCTIONS. THE ETIOLOGY WAS REPORTED TO BE OF THE INCISIONAL SITE/DEVICE TRACT; THE LUMBAR SITE. THE EVENT WAS NOTED TO NOT BE RELATED TO DEVICE OR THERAPY AND WAS REPORTED TO BE RELATED TO THE IMPLANT PROCEDURE. THE SIGN AND SYMPTOM THE PATIENT EXPERIENCED WAS SURGICAL WOUND OPENING OF THE LUMBAR SITE. THE TYPE OF MEDICATION BEING ADMINISTERED VIA THE DEVICE SYSTEM WAS UNKNOWN. IT WAS LATER REPORTED THAT THE PATIENT RESOLVED WITHOUT SEQUELAE WITH A RESOLVED DATE OF (B)(6) 2012. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27837 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention