BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4903624 · Received July 9, 2015

    Report

    Report Number
    2124215-2015-08759
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 19, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED HIGH OUT-OF-RANGE PACING IMPEDANCES. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED OBTAINING A CHEST X-RAY DUE TO POTENTIAL LEAD FRACTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE ASSOCIATED DEVICE WAS PROGRAMMED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446797 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR 4469| A135| 0157| E110