BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK DSP

    MDR report key: 2781017 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13502
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 27, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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) DEFIBRILLATION LEAD EXHIBITED NOISE, OVERSENSING AND INAPPROPRIATE SHOCKS. IT WAS NOTED THAT THE LEAD WAS PARTIALLY FRACTURED. A REVISION PROCEDURE WILL BE PERFORMED TO SURGICALLY CAP AND REPLACE THE LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS OTHER THAN THE ADDITIONAL PROCEDURE WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R 0125| 4518| H215| 4068| 1810| 7274| MISMATCH