BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780994 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13268
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 27, 2012
    Report Date
    October 18, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS LEAD HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED SET SCREW MARKS ON THE IS-1 TERMINAL PIN AND THE DISTAL AND PROXIMAL HIGH VOLTAGE TERMINAL PINS. THERE WERE NO DISCERNABLE SET SCREW MARKS NOTED ON THE IS-1 RING. THE INSULATION WAS CUT AT THE SUTURE SLEEVE TIE DOWN SITE AND IN THE SUTURE SLEEVE AS WELL. THE GORE COVERING WAS BUNCHED IN SEVERAL PLACES. THE HELIX WAS RETRACTED AND APPEARS INTACT AND UNDAMAGED. THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED BY ANALYSIS. THE LEAD TIP AND HELIX APPEAR INTACT AND UNDAMAGED. THE LEAD PASSED ELECTRICAL TESTING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION ALSO INDICATED THERE WERE INAPPROPRIATE SHOCKS DELIVERED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW SENSING MEASUREMENTS AT 2.5 MILLIVOLTS AND HIGH THRESHOLD MEASUREMENT OF 4.5 VOLTS AT 0.8 MILLISECONDS. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS FOUND TO HAVE DISLODGED. THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| R 4135| 0180| E110