BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4132247 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15363
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 24, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DURING A ROUTINE FOLLOW-UP, THE RIGHT VENTRICULAR (RV) LEAD NOTED AN INCREASE IN PACING IMPEDANCE MEASUREMENTS FROM 800 TO 1347 OHMS. ADDITIONALLY, HIGH THRESHOLD MEASUREMENTS AND LOSS OF CAPTURE WERE NOTED. WITH THE LOSS OF CAPTURE, THE PATIENT REPORTED WORSENING HEART FAILURE SYMPTOMS AND SHORTNESS OF BREATH. THE PATIENT WAS HOSPITALIZED AND THE NEXT DAY A REVISION PROCEDURE WAS PERFORMED. THE X-RAY INDICATED AN INTEGRITY ISSUE WITH THE RV LEAD. THIS INTEGRITY ISSUE WAS LIKELY INSULATION DAMAGE IN THE POCKET. AS A RESULT, THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612589 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4096| G141| 0158| 4592