BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPICARDIAL PATCH

    MDR report key: 1990620 · Received February 15, 2011

    Report

    Report Number
    2182208-2011-00134
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 11, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P900061/S2
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF THE LEAD A DEFORMATION OF THE PATCH ELECTRODE WAS FOUND THROUGH AN X RAY PHOTO. THE LEAD IMPEDANCE WAS NORMAL AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPICARDIAL PATCH IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6721M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other D234DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4968 X2 IMPLANTABLE PACING LEAD