BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043254 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02561
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 23, 2013
    Report Date
    February 13, 2013
    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

    UPON RETURN AND ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUT POST MARKET QUALITY ASSURANCE LABORATORY THE LEAD WAS RETURNED SEVERED. VISUAL INSPECTION REVEALED PORTION OF THE LEAD BODY AND/OR MISSING INSULATION, THE IRS- COIL EXTENDED, THE DISTAL AND PROXIMAL HIGH VOLTAGE CABLE EXTENDED, AS WELL AS THE SETSCREW MARKS ON EACH PORTION BESIDES THE IS-RING. IN ADDITION, THE DISTAL END OF THE PROXIMAL SPRING ELECTRODE WAS SEPARATED. ALL DAMAGE APPEARED TO BE RELATED TO THE EXPLANT PROCEDURE. THE LEAD WAS FURTHER TESTED AND WAS ELECTRICALLY CONTINUOUS. LABORATORY ANALYSIS COULD NOT CONFIRM THE FIELD ALLEGATIONS AND THE RETURNED SEGMENTS OF THE LEAD PASSED ELECTRICAL TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD HAD HIGH OUT OF RANGE PACING IMPEDANCES. THE LEAD WAS EXPLATNED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145276 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R