BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4148705 · Received October 7, 2014

    Report

    Report Number
    2124215-2014-14380
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 24, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE RV LEAD WAS SURGICALLY ABANDONED. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH SHOCKING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. ADDITIONAL INFORMATION INDICATED THAT THE CAUSE WAS NOT DETERMINED. A LEAD REVISION WAS SCHEDULED. THIS DEVICE AND LEAD WAS RE-PROGRAMMED AND REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629570 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R T165| E143| 4470| 0185