BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173251 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10590
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 15, 2011
    Report Date
    September 29, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY ANALYSIS REVEALED ALL THE RATE SENSE CONDUCTOR COILS WERE FRACTURED APPROXIMATELY 17.2 CM FROM IS-1 PIN, ABOUT 2 CM FROM DISTAL END OF SUTURE SLEEVE TIED-DOWN.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED LATER THAT INDICATED A REVISION PROCEDURE WAS SCHEDULED DUE TO A LEAD FRACTURE. INFORMATION WAS LATER RECEIVED THAT THE LEAD WAS EXPLANTED DUE TO A FRACTURE, HIGH IMPEDANCE MEASUREMENTS AND LOSS OF CAPTURE. NO ADVERSE PATIENT EFFECTS WERE NOTED. INFORMATION WAS RECEIVED LATER THAT INDICATED A REVISION PROCEDURE WAS SCHEDULED DUE TO A LEAD FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 0185| 4538| 4136| H210