BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3905799 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11594
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCES GREATER THAN 2,000 OHMS AND HIGH PACING THRESHOLDS. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. INFORMATION WAS LATER RECEIVED INDICATING THE PATIENT WAS NOT PACEMAKER DEPENDENT AND THE CAUSE OF THE OUT OF RANGE IMPEDANCES WAS NOT DETERMINED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE ICD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382652 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0286

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0692| 0286