BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45

    MDR report key: 1822591 · Received September 1, 2010

    Report

    Report Number
    3005075853-2010-05016
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 9, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT DURING A LIVER RESECTION PROCEDURE, WHEN THE FLEX WAS FIRED ACROSS THE LIVER THE CARTRIDGE WAS PUSHED OUT. THE SURGEON THINKS THE SCRUB NURSE COULDN`T HAVE PUT THE CARTRIDGE IN CORRECTLY. IT IS POSSIBLE THAT THE CARTRIDGE WAS NOT FULLY CLICKED INTO PLACE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT A LONGEVITY ESTIMATE WAS REQUESTED FOR THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D); HOWEVER, THERE WAS NO ACCESS TO HISTORICAL VOLTAGE DATA. THIS DEVICE IS INCLUDED IN THE SHORTENED REPLACEMENT WINDOW (SRW) ADVISORY. TECHNICAL SERVICES (TS) DID NOT PROVIDE A LONGEVITY CALCULATION AND RECOMMENDED MONTHLY FOLLOW UP VISITS UNTIL THE SRW STATUS WAS CONFIRMED WITH VOLTAGE INFORMATION. AT THIS TIME, IT IS UNCERTAIN WHETHER THIS DEVICE IS AFFECTED BY THE SRW ADVISORY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1