BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043605 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02544
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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 THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED INCREASING PACING THRESHOLD MEASUREMENTS AT 3.5 AT 0.5MS. ADDITIONALLY, PACING IMPEDANCE MEASUREMENTS HAD INCREASED FROM THE PREVIOUS YEAR AT 550 OHMS TO 1,100 OHMS. DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE, THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE RV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147107 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R T175| 0148