BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040666 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00685
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD HAD FALLEN ON THEIR LEFT SHOULDER RESULTING IN PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THERE WAS ALSO NOISE, OVERSENSING AND INAPPROPRIATE SHOCKS OBSERVED. THE PATIENT WAS EVALUATED AND A REVISION PROCEDURE WAS PERFORMED. THE PACE/SENSE PORTION OF THIS LEAD WAS SURGICALLY CAPPED AND ABANDONED. THE SHOCKING PORTION OF THIS PRODUCT REMAINS IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143619 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 4470| E110| 4320| 1705| 0185| 0041| T165| 1625| 1645