BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2993249 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03458
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 7, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID, 8598A SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8578 SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS FOUND TO HAVE FLIPPED IN THE POCKET. DURING A REFILL APPOINTMENT, THE PHYSICIAN FLIPPED THE PUMP BACK INTO PLACE IN ORDER TO FINISH THE REFILL. IT WAS NOTED THAT PATIENT HAD NOTICED THE PUMP CHANGING POSITION UNDER THE SKIN AND HAD DISCOMFORT IN HIS UPPER, LEFT QUADRANT THAT PREVENTED HIM FROM BEING ABLE TO LIE ON HIS SIDE. ADDITIONALLY, IT WAS UNCOMFORTABLE FOR THE PATIENT TO BEND FORWARD. THE PATIENT HAD BEEN SCHEDULED FOR A PUMP REVISION SURGERY. EIGHT DAYS LATER, IT WAS REPORTED THAT THE PUMP HAD BEEN "NONFUNCTIONAL" DUE TO THE SLIPPING IN THE SUBCUTANEOUS POCKET. IT WAS STATED THAT THE PATIENT WAS DOING WELL AND THE PUMP HAD BEEN FUNCTIONING "REASONABLY WELL" PRIOR TO FLIPPING. DURING THE PROCEDURE, INTRA-OPERATIVE ANTIBIOTICS WERE GIVEN TO THE PATIENT. THE PATIENT WAS NOTED TO HAVE BEEN IN STABLE NEUROLOGICAL CONDITION WHEN TAKEN TO THE RECOVERY ROOM. IN ADDITION, THE PUMP WAS REPROGRAMMED AFTER THE PROCEDURE. THE DRUG USED IN THE PUMP WAS COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97725 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention