BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1770241 · Received July 21, 2010

    Report

    Report Number
    3004209178-2010-05667
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    June 21, 2010
    Report Date
    June 23, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT UNDERWENT PUMP REPLACEMENT SURGERY. FOLLOWING SURGERY, THE PT EXPERIENCED INCREASED SPASTICITY. THE PT WAS "NOT DOING GOOD" AND WAS HOSPITALIZED. ON (B)(6) 2010, THE PT WAS TAKEN TO SURGERY. DURING SURGERY, IT WAS FOUND THAT THE CATHETER WAS COMPLETELY CUT IN THE PUMP POCKET. THE SURGEON THOUGHT THAT HE PROBABLY CAUGHT THE CATHETER IN A RETRACTOR DURING THE PUMP REPLACEMENT TWO DAYS PRIOR. THE CATHETER WAS REVISED. THE SURGEON WAS ABLE TO GET AMPLE CSF RETURN WHEN THE CATHETER WAS ASPIRATED. THE PT WAS BOLUSED WITH 200MCG OF LIORESAL IN ADDITION TO THE PRIMING BOLUS OF THE CATHETER. THE NEXT MORNING, THE PHYSICIAN SAW THE PT. THE PT'S SPASTICITY WAS MUCH IMPROVED AND HE WAS GOING TO BE DISCHARGED TO HOME THAT MORNING. THE PUMP DELIVERED LIORESAL 2000 MCG/ML AT 1100 MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization| R IMPLANTED:| IMPLANTED:| LOT# NGV004382N| EXPLANTED:| CATHETER: MODEL 8731, LOT# N002575105| EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 863740,