BEUDAMED
    FDA Adverse Event Other Summary report: N

    X-STOP IPD SYSTEM

    MDR report key: 1455902 · Received August 26, 2009

    Report

    Report Number
    2953769-2009-00110
    Event Type
    Other
    Date Received
    August 26, 2009
    Report Date
    July 27, 2009
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NQO
    PMA / PMN Number
    P040001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: PRESENTATION TITLED "PATIENT SATISFACTION & OUTCOMES FOLLOWING INTERSPINOUS PROCESS DEVICE DECOMPRESSION OF LUMBAR SPINAL STENOSIS", BY AMIT O. AGARWALA, M.D., WENDY DOD, CCRP, COURTNEY W. BROWN, M.D., DOUGLAS C. WONG, M.D., THOMAS J. PUSCHAK, M.D. METHOD - DEVICE NOT RETURNED, FOLLOW UP WITH AUTHOR. UNSUCCESSFUL ATTEMPTS WERE MADE TO FOLLOW UP WITH THE AUTHOR VIA PHONE AND EMAIL. NO FURTHER INFORMATION WAS AVAILABLE. UNABLE TO CONFIRM THAT DATA PROVIDED MATCHES INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC SPINE LLC.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PRESENTATION THE FOLLOWING EVENTS: 9 REVISION SURGERIES. IT IS BELIEVED THAT THESE HAVE PREVIOUSLY BEEN REPORTED AS: MDR NUMBER (2953769-2008-00047): ONE CASE WHERE A PATIENT DEVELOPED A LARGE HERNIATED DISK AT THE OPERATIVE LEVEL THAT REQUIRED REVISION TO LAMINECTOMY; PRESENTED AS SENSORY/MOTOR RADICULOPATHY. MDR NUMBER (2953769-2008-00046): ONE CASE WHERE A PATIENT DEVELOPED A LARGE HERNIATED DISK AT THE OPERATIVE LEVEL THAT REQUIRED REVISION TO LAMINECTOMY; PRESENTED WITH CAUDA EQUINA SYNDROME. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-STOP IPD SYSTEM INTERSPINOUS PROCESS SPACER NQO MEDTRONIC SPINE LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other