BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3213790 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10237
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    March 28, 2013
    Report Date
    August 12, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LEAD HAS BEEN RETURNED. BOSTON SCIENTIFIC HAS CONCLUDED IT IS UNLIKELY THAT LEAD CHARACTERISTICS CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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 THIS RIGHT VENTRICULAR (RV) LEAD WAS DISLODGED. IT WAS FOUND OUT TWO WEEKS AFTER THE IMPLANT PROCEDURE. THE LEAD¿S SENSING CAPACITY WAS DECREASED AND NO CAPTURE WAS MADE EVEN IN MAXIMUM OUTPUT. THE CAUSE WAS UNKNOWN. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE MEDICAL REPRESENTATIVE WAS MADE AWARE OF THE DISLODGEMENT ON THE DAY OF THE REVISION PROCEDURE. THUS, A LONGER LEAD WAS NEEDED AND THE PHYSICIAN IMPLANTED A NEW LEAD AS REPLACEMENT. THE LEAD WAS EXPLANTED AND OUT OF SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313479 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| L| R 0296| E160