BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTHROCARE SPINEWAND

    MDR report key: 1912747 · Received October 6, 2010

    Report

    Report Number
    2951580-2010-00079
    Event Type
    Other
    Date Received
    October 6, 2010
    Date of Event
    January 1, 2008
    Report Date
    October 6, 2010
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    HRX
    PMA / PMN Number
    K010811
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTHROCARE HAS MADE SEVERAL ATTEMPTS TO OBTAIN THE COMPLETE PT INFORMATION, DATE OF EVENT, AND FLUORO SCAN FOR THIS REPORT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO DATE FROM THE USER FACILITY. THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. SINCE THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION AND THE LOT NUMBER IS NOT KNOWN, A COMPLETE INVESTIGATION COULD NOT BE COMPLETED. NO CONCLUSION CAN BE MADE.

    Description of Event or Problem · 1

    TWO YEARS FOLLOWING A PLASMA DISC DECOMPRESSION PROCEDURE, THE PHYSICIAN REPORTED THE LOOP FROM THE ARTHROCARE SPINEWAND WHICH HAD DETACHED IN THE ORIGINAL PROCEDURE AND WAS LEFT IN THE PT APPEARED TO BE MIGRATING IN THE NUCLEUS OF THE PT'S DISC. THE LOOP APPEARED TO BE MIGRATING POSTERIORLY. THE PT HAD SUBSEQUENT PROCEDURES BUT NOT AT THE SAME LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROCARE SPINEWAND ELECTROSURGICAL CUTTING & COAGULATION DE HRX ARTHROCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other