BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2792712 · Received October 16, 2012

    Report

    Report Number
    2124215-2012-14054
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    September 13, 2012
    Report Date
    April 2, 2024
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073/S043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE DUE TO TWIDDLER'S SYNDROME. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Life Threatening| H| R (B)(6)| 0184| 0295| 1298| 284-09| 430-10| 438-10-52| 4480| 4542| E110| N160| ZY52PJUSBV| E110| 4480| 438-10-52| 430-10| 284-09| 0295| N160| 0184| 4542| 1298