BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3241939 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12133
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    July 2, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ANKYLOSING SPONDYLITIS. THE PAIN MANAGEMENT SPECIALIST DEEMED THAT THE PATIENT NEEDED TO HAVE THE PUMP TAKEN OUT. THE PATIENT¿S PRIMARY HEALTH CARE PROVIDER (HCP) WOULD NOT TAKE IT OUT STATING THAT IT WAS DETRIMENTAL TO THE PATIENT¿S HEALTH TO HAVE IT REMOVED. THE PATIENT WAS CURRENTLY LOOKING FOR A NEW DOCTOR TO REMOVE THE PUMP. THE PUMP WAS INFUSING SALINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DISEASE CAUSED SPINAL FUSION AND WAS A RARE TYPE OF ARTHRITIS. IT WAS REPORTED IT HAD NOTHING TO DO WITH THE PUMP BUT BECAUSE OF THE CATHETER IN THE SPINE AND THE SPINAL ISSUES IT WAS NOTED TO NOT BE WISE TO CONTINUE WITH THE TYPE OF THERAPY. IT WAS REPORTED THE BONE COULD FUSE AROUND THE CATHETER AND CAUSE ISSUES. THERE WERE NO DEVICE ISSUES AT ALL AND IT ALL PERFORMED AS IT SHOULD. IT WAS STRICTLY BECAUSE OF THE DIAGNOSIS OF THE DISEASE. THE DATE OF DIAGNOSIS WAS NOT AVAILABLE HOWEVER IT WAS NOTED IT WAS RECENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340157 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention