BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1840820 · Received September 16, 2010

    Report

    Report Number
    3007566237-2010-07017
    Event Type
    Death
    Date Received
    September 16, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 23, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2276-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL DEVICE ANALYSIS WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP MEDWATCH REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE AND/OR WHEN ADDITIONAL INFORMATION IS RECEIVED FROM THE HCP.

    Description of Event or Problem · 1

    THE PUMP WAS REFILLED (B)(6)2010 WITH BACLOFEN 2,000MCG/ML AND SET AT A DOSE OF 12.5MCG/DAY. LATE THE FOLLOWING SATURDAY, THE PATIENT AWOKE SCREAMING IN PAIN AND HIS MOTHER GAVE HIM 20MG ORAL BACLOFEN AND SOMA. HE AWOKE IN PAIN AGAIN AT 5:30AM SUNDAY AND WAS GIVEN AN ADDITIONAL 20MG OF ORAL BACLOFEN; THE PARAMEDICS WERE CALLED. THEY ARRIVED AT 8:00AM SUNDAY AND TRANSPORTED THE PATIENT TO THE EMERGENCY DEPARTMENT. THE PATIENT ARRIVED UNRESPONSIVE AND WITH A TEMPERATURE OF 109. HE WAS PRONOUNCED DEAD AT 9:30AM THAT DAY. THE MEDICAL EXAMINER BELIEVED BACLOFEN WITHDRAWAL WAS A POSSIBLE CAUSE OF DEATH. TELEMETRY STRIPS CORRELATING TO PUMP EXAMINATION ON (B)(6)2010 INDICATED THAT THE PUMP HAD RESET AND WAS IN SAFE STATE. ANALYSIS RESULTS WERE PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death EXPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8711, LOT# N122984005| IMPLANTED:| CATHETER: MODEL 8731, LOT# N001335401