BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK DSP

    MDR report key: 2911913 · Received January 11, 2013

    Report

    Report Number
    2124215-2013-00611
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 5, 2012
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    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 THIS RIGHT VENTRICULAR (RV) LEAD LEAD EXHIBITED NOISE WHICH RESULTED DETECTIONS AND DIVERTED SHOCKS. DUE TO THE LEADS AGE, THE PHYSICIAN DECIDED TO REPLACE THE LEAD. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS SURGICALLY ABANDONED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18115 ENDOTAK DSP IMPLANTABLE LEAD NVY HISTORICAL PUERTO RICO 0095

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R 0095| 1763| 1625| 0062| 1860| E102