BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201462 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11175
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    June 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
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8780 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER CLARIFIED REGARDING THE DYE GOING TO THE TIP OF THE CATHETER THAT THE NEUROSURGEON THEORIZED THE PATIENT HAD AN ABNORMAL SPINE. IT WAS UNKNOWN IF THAT CAN BE PROVEN BUT WAS THOUGHT THIS ISSUE WAS NOT RELATED TO THE CATHETER. IT WAS NOT KNOWN HOW THE PATIENT WAS DOING CURRENTLY.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE ¿CATHETER FUNCTIONING BUT LACK OF RELIEF¿. THE PATIENT HAD DENIED ANY RELIEF FROM HIS SPASTICITY SINCE (B)(6) IMPLANT. THE PATIENT EXPERIENCED LESS THAN 50% OF THERAPY RELIEF. A DYE STUDY WAS PERFORMED IN INTERVENTIONAL RADIOLOGY AND THE CATHETER COULDN¿T BE ASPIRATED. IN THE OPERATING ROOM (OR) A DYE STUDY WAS DONE AND THE CATHETER WAS ASPIRATED. THE DYE WENT TO THE TIP OF THE CATHETER BUT DID NOT FALL DOWN BUT WENT UP. BECAUSE OF THIS A NEW SPINAL SEGMENT WAS PLACE ONE LEVEL HIGHER. THE PATIENT OUTCOME WAS NOTED AS ALIVE, NO INJURY, NO ADVERSE EVENT. THE PUMP WAS USED TO DELIVER GABLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303117 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention