BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3904240 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-12765
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    February 25, 2013
    Report Date
    April 3, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    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 ONE YEAR AGO, THIS PATIENT WAS ADMITTED TO THE HOSPITAL FOR SYMPTOMS RELATED TO HEART FAILURE. A CHEST X-RAY WAS LATER TAKEN AND THEN REVIEWED BY AN INDEPENDENT LAB AT A LATER DATE. THE X-RAY REVEALED THAT BOTH THE RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEADS HAD FRACTURED. ATTEMPTS TO OBTAIN PERTINENT ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE RV AND LV LEADS CURRENTLY REMAIN IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384916 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 1688TC| 4555| 0185| N119