BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK DSP

    MDR report key: 3043095 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01893
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 18, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABANDONED LEAD WAS NOT RETURNED TO BOSTON SCIENTIFIC THEREFORE, THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD CAUSED A RED ALERT TO BE DECLARED DUE TO HIGH PACING IMPEDANCES. FURTHER REVIEW REVEALED THAT NOISE WAS ALSO PRESENT ON THE LEAD. A REVISION PROCEDURE WAS PERFORMED AND THE RV LEAD WAS AGAIN TESTED WHICH CONFIRMED NOISE. NO DAMAGE OF THE LEAD COULD BE FOUND. THE SUSPECTED CAUSE OF THE NOISE WAS DUE TO THE LOCATION WHERE THE LEAD AS IT WAS NEAR THE SUBCLAVIAN. THE RV LEAD WAS SURGICALLY ABANDONED AND THEREFORE WILL NOT BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146166 ENDOTAK DSP IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R