BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBQ

    MDR report key: 4210829 · Received October 29, 2014

    Report

    Report Number
    2182208-2014-03122
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 28, 2014
    Report Date
    September 29, 2014
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS IN THE SAME BRAND FAMILY AS A DEVICE MARKETED IN THE U.S. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH IMPEDANCE DUE TO A LEAD FRACTURE ON THE RIGHT VENTRICULAR (RV) LEAD. A LEAD REVISION HAS BEEN ADVISED AND THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694012 SUBQ LWS 6996S

    Patients

    Seq Age Sex Outcome Treatment
    1 6996 LEAD, 4968 LEAD IMPLANT UNK