BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1871910 · Received October 16, 2010

    Report

    Report Number
    2124215-2010-17416
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    August 28, 2010
    Report Date
    September 3, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT WAS EXPLANTED AND REPLACED. AS OF TODAY, THIS PRODUCT HAS NOT BEEN RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THIS PRODUCT REMAINS IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THE RV LEAD WAS EXTRACTED DUE TO FRACTURE AND THE PATIENT'S ICD WAS REPLACED AND THE PATIENT WAS UPGRADED TO A BIVENTRICULAR DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCES GREATER THAN 2000 OHMS AND ALSO A SHORTED LEAD FAULT DUE TO A SHOCK IMPEDANCE OF 20 OHMS. IT WAS REPORTED THAT THE PATIENT RECEIVED SHOCK THERAPY FOR A TRUE VENTRICULAR FIBRILLATION (VF) EPISODE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS TO UNDERGO A REVISION PROCEDURE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention T177| E102| 0157