BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3142115 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08510
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS BEING DONE TO THE PUMP POCKET DUE TO PUMP POCKET EROSION. THE PLANS WERE TO MOVE THE PUMP TO ANOTHER POCKET SITE. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. IT WAS LATER REPORTED THAT THE PRE-OP DIAGNOSIS WAS ¿PRESSURE NECROSIS". THE PUMP WAS EXPLANTED FROM THE RIGHT SIDE AND A NEW PUMP WAS IMPLANTED ON THE LEFT SIDE. THE SPINAL SEGMENT OF THE CATHETER WAS SPLICED AND A NEW PUMP SEGMENT ADDED TO ACCOMMODATE THE NEW PUMP TO THE LEFT SIDE. THE PATIENT SYMPTOMS INCLUDED DRAINAGE/INCISIONAL WOUND OPENING AND PAIN. IT WAS LATER REPORTED THAT CULTURES WERE TAKEN OF THE POCKET INTRA-OP; RESULTS WERE UNKNOWN. THE PATIENT OUTCOME WAS REPORTED AS ¿STABLE¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245029 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention