BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK SQ

    MDR report key: 1894437 · Received November 9, 2010

    Report

    Report Number
    2124215-2010-21616
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS SUB-Q ARRAY REMAINS ACTIVELY IN SERVICE. NO NEW INFORMATION HAS BECOME AVAILABLE, THEREFORE THIS INVESTIGATION WILL BE CLOSED. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS SUB-Q ARRAY IN ASSOCIATION WITH THE COMPETITOR'S DEVICE EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENT, POSSIBLY >125 OHMS. THE COMPETITIVE REPRESENTATIVE WAS ATTEMPTING TO DETERMINE THE SOURCE OF THE ISSUE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK SQ IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0049

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR 0049| 1831| 4245| 1853| 0144