BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3092666 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07291
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 11, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INCREASED SPASTICITY IN HER UPPER EXTREMITIES SINCE "SOMETIME IN JANUARY" OF 2013, AFTER BEING INJURED DURING A DOMESTIC DISPUTE. ON (B)(6) 2013, A ROTOR STUDY WAS DONE THAT SHOWED THE ROTORS TO BE TURNING. A DYE STUDY WAS ALSO DONE AND SHOWED "GOOD FLOW" INTO THE CATHETER. ADDITIONALLY, THE CATHETER WAS EASILY ASPIRATED. "ABOUT A WEEK" PRIOR TO THIS REPORT DATE, THE PATIENT HAD A DOCTOR APPOINTMENT AND RECEIVED A "50 MCG BOLUS." THIS BOLUS DID NOT RESULT IN ANY EFFECT. THE PUMP WAS REPLACED. THE PATIENT STATUS WAS REPORTED TO BE "ALIVE - NO INJURY/NO ADVERSE EVENT." THE PUMP WAS DELIVERING LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193653 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention