BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1830800 · Received September 8, 2010

    Report

    Report Number
    3004209178-2010-06874
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 10, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT'S DOSAGE WAS INCREASED TO 342MCG AND WAS NOT RESPONDING AS WELL AS DURING TRIAL. PATIENT'S WIFE STATED INITIALLY SPASTICITY IMPROVED SLIGHTLY BUT NOW DOES NOT SEEMED TO BE IMPROVING FOLLOWING A NEW PUMP AND CATHETER IMPLANT. THE PATIENT WAS IN A REHABILITATION HOSPITAL FOR BRAIN INJURY AT THE TIME. THE PUMP CONTAINED LIORESAL (BACLOFEN) 500 MGC/ML WITH DOSAGE UNKNOWN. IT WAS NOTED NO DEVICE TROUBLESHOOTING AND/OR INTERVENTION WAS NEEDED AT THE TIME AND PUMP WAS WORKING FINE. IT WAS FURTHER REPORTED ONE WEEK LATER, AN OVERDOSE OCCURRED AND PATIENT HAD RESPIRATORY DISTRESS, VOMITING, LOOSE LIMBS, AND A BLOOD PRESSURE OF 97/45. THE SYMPTOMS HAD OCCURRED DURING A NORMAL REFILL CYCLE. PATIENT'S WIFE STATED THE DOSE WAS CHANGED A COUPLE DAYS BEFORE FROM 390 TO 450 MCG/DAY. IT WAS NOTED, THIS WAS THE FIRST OCCURRENCE AND PATIENT WAS ADMITTED TO HOSPITAL. X-RAYS OF THE PUMP SYSTEM WERE PERFORMED AND NO PROBLEMS WERE FOUND. IT WAS NOTED OVERDOSE WAS NOT SEEN UNTIL 3 DAYS AFTER DOSE WAS INCREASED. MANUFACTURER REPRESENTATIVE STATED, IT WAS UNCERTAIN AS TO THE CAUSE OF THE EVENT AND THAT IT APPEARED THE DEVICE WAS NOT AN ISSUE. IT WAS NOTED PUMP WAS TURNED DOWN AND PATIENT WAS DOING BETTER. ADDITIONAL INFORMATION WILL BE PROVIDED WHEN AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| CATHETER: MODEL 8709SC, LOT # N255698002| CATHETER: MODEL 8596SC, LOT # N251598003| EXPLANTED:| IMPLANTED:| IMPLANTED: