BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK DSP

    MDR report key: 2941551 · Received February 4, 2013

    Report

    Report Number
    2124215-2013-02370
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    November 1, 2011
    Report Date
    December 6, 2012
    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

    THE LEAD IS NOT AVAILABLE FOR ANALYSIS. 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 HAD FRACTURED AT THE LEAD YOKE. A REVISION PROCEDURE WAS PERFORMED. THE LEAD HAD STARTED TO UNCOIL DURING THE PROCEDURE AT WHICH VASCULAR SURGERY WAS PERFORMED TO EXPLANT THE LEAD. THE LEAD WAS SUCCESSFULLY EXPLANTED. ANOTHER MANUFACTURER'S LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47181 ENDOTAK DSP IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| L| R MISMATCH| 1782| T135| 1861| 0125