BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK DSP

    MDR report key: 2040822 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-02098
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS INACTIVELY IMPLANTED. 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 CHRONIC RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED THRESHOLD AND IMPEDANCE MEASUREMENTS. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND SIGNS OF INSULATION DAMAGE WERE OBSERVED. THE RV LEAD WAS CAPPED AND REPLACED WITHOUT COMPLICATION. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK DSP IMPLANTABLE LEAD NVY GUIDANT PUERTO RICO BV 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR 0184| 1743| 6836| 1600| 1860| (B)(4)| 0074| 0064| 0063| 0125