BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2930081 · Received January 25, 2013

    Report

    Report Number
    2124215-2013-01940
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    December 3, 2012
    Report Date
    January 30, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    --

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE FIELD REPRESENTATIVE INDICATED THAT THIS PATIENT HAD A FRACTURED COMPETITOR'S RIGHT VENTRICULAR (RV) LEAD LEAD. THE FIELD REPRESENTATIVE CONFIRMED THAT THERE WAS NO INFECTION AND THE PATIENT RECEIVED A NEW BSC RV LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD DEVELOPED AN INFECTION AND A REVISION PROCEDURE WILL BE SCHEDULED IN THE NEAR FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35878 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R 4018| 4472| E110| 0157| 1270| 1298| 1290| 4244| 7120