BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053630 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05034
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 24, 2013
    Report Date
    March 27, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS SURGICALLY ABANDONED AND THERE WILL BE NO RETURN OF PRODUCT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AN AMENDED REPORT WILL BE PREPARED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE DEVICE WAS ALSO REPLACED TO AVOID A FURTHER PROCEDURE. THERE WAS NO ALLEGATION AGAINST THE DEVICE. POST PROCEDURE, ALL MEASUREMENTS WERE ACCEPTABLE AND SUCCESSFUL DFT TESTING WAS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR LEAD RECEIVED FIVE INAPPROPRIATE SHOCKS AND PRESENTED TO THE EMERGENCY ROOM FOR DEVICE INTERROGATION. VALSALVA MANEUVERS ON THE POCKET REPRODUCED NOISE. IN ADDITION, HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS WERE DISPLAYED. LEAD FRACTURE WAS SUSPECTED. THE PATIENT REMAINS HOSPITALIZED AND MONITORED UNTIL AN INTENDED REVISION PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155878 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0128

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R