BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPER VIEW SUPER 7

    MDR report key: 1022178 · Received March 26, 2008

    Report

    Report Number
    3005099803-2008-00305
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED; THEREFORE, A DEVICE EVALUATION IS NOT AVAILABLE AND THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE DEVICE HISTORY RECORD OF THE PERTINENT LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. A REVIEW OF THE COMPLAINT DATABASE REVEALED TWO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THE LOT (BY THE SAME CUSTOMER DURING THE SAME PROCEDURE). THE FEBRUARY 2007 15-MONTH BAND LIGATION PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE THIRD OF THREE DEVICES THAT WERE USED DURING THE SAME PROCEDURE. ACCORDING TO THE COMPLAINANT, THE DEVICE EITHER FAILED TO FIRE OR DEPLOYED MULTIPLE BANDS RATHER THAN A SINGLE BAND. THE PROCEDURE WAS COMPLETED WITH A FOURTH SPEEDBAND SUPER VIEW SUPER 7 LIGATOR DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. REFER TO MANUFACTURER REPORTS: 3005099803-2008-00306 AND 3005099803-2008-00307 FOR DETAILS REGARDING THE OTHER TWO DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPER VIEW SUPER 7 MND BOSTON SCIENTIFIC CORPORATION M00542250 11329728

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK