BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3191146 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10920
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 3, 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
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8590-1, LOT# N330139, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: ACCESSORY: PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: ACCESSORY: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT DIAGNOSTICS WERE PERFORMED ON (B)(6) 2013 INCLUDING AN X-RAY OF THE SPINE AND USE OF A C-ARM. THE CATHETER WAS NOT SEEN UNDER FLUORO. THE HEALTHCARE PROVIDER (HCP) BELIEVED THAT THE CATHETER HAD WITHDRAWN FROM THE INTRATHECAL SPACE AND WAS COILED IN THE PUMP POCKET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE 2 FLUID FILLED AREAS ON THE PATIENT¿S BACK NEAR WHERE THE CATHETER WAS PLACED. ON AREA ABOVE THE CATHETER WAS SMALLER AND HAD NOT CHANGED IN SIZE BUT THE AREA BELOW THE CATHETER WAS LARGER AND WAS INCREASING IN SIZE. THE PATIENT¿S DOSE WAS INCREASED BY 10% AND THE PATIENT STILL HAD QUITE A FEW SPASMS BUT HAD SHOWN IMPROVEMENT. THE PATIENT WAS CURRENTLY BEING FOLLOWED UP BY A LOCAL DOCTOR. THE DEVICE SYSTEM DELIVERED BACLOFEN. IT WAS LATER REPORTED THAT THE SWELLING IN THE PATIENT¿S BACK HAD PERSISTED. THE PATIENT¿S HEALTHCARE PROVIDER (HCP) HAD EVALUATED HIM AND WAS NOT CONCERNED; HOWEVER, THE CALLER PERFORMED A PUMP REFILL ON THE DAY OF THE REPORT AND NOTICED THE SWELLING WAS LARGER. THE CALLER STATED THAT THE PATIENT DID NOT HAVE A SPINAL HEADACHE OR ANY OTHER SYMPTOMS OTHER THAN THE SWELLING. THE CALLER STATED THAT THE SWELLING DID NOT FEEL HOT, LOOK UNUSUAL OR ¿ANGRY¿. THE PATIENT WAS SCHEDULED TO SEE HIS PHYSICIAN ON THE FOLLOWING MONDAY. IT WAS LATER REPORTED THAT THE PATIENT HAD RECEIVED DOSE ADJUSTMENTS EVERY MONTH SINCE DEVICE IMPLANT AND WAS NOT RECEIVING THE THERAPEUTIC RELIEF THAT HE EXPECTED TO GET FROM THE SPASMS AND MUSCLE TIGHTNESS OR TONE. THE PATIENT REPORTED THAT THE SWELLING ON HIS BACK WAS 5¿ BY 4¿ WHERE THE SURGERY WAS PERFORMED AND CONTINUED TO GET LARGER. THE PATIENT WORE A BINDER OVER THE AREA FOR WEEKS. THE PATIENT¿S DOCTORS WERE AWARE OF THIS AND DID NOT THINK IT WAS A PROBLEM. IT WAS LATER REPORTED THAT DUE TO THE ENLARGING SEROMA ON THE PATIENT¿S BACK THE CATHETER EVENTUALLY MIGRATED AND HAD TO BE REPLACED. THE CATHETER REPLACEMENT TOOK PLACE IN (B)(6) 2013. THE PATIENT HAD EXPERIENCED INCREASED BILATERAL WEAKNESS AND NUMBNESS IN HIS EXTREMITIES. IT WAS NOTED THAT THE PATIENT HAD A LOT OF ARTHRITIS AND FROM A PREVIOUS TRAUMA TO HIS SPINE FROM A MOTORCYCLE ACCIDENT IT WAS VERY DIFFICULT TO INITIALLY PLACE THE CATHETER. FOLLOWING THE CATHETER REVISION THE SEROMA FULLY RESOLVED AND THE PATIENT RECEIVED EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291107 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention