BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043585 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02514
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    October 19, 2012
    Report Date
    February 19, 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

    THE RV LEAD REMAINS IN SERVICE AND A REVISION PROCEDURE MAYBE PERFORMED IN THE NEAR FUTURE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE ABANDONED LEAD WAS NOT RETURNED TO BOSTON SCIENTIFIC THEREFORE, THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED. 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 DURING A ROUTINE FOLLOW-UP VISIT, THIS RIGHT VENTRICULAR (RV) LEAD REVEALED A RISE IN PACING IMPEDANCES GREATER THAN 2,000 OHMS. IN ADDITION, NOISE WAS OBSERVED WHICH CAUSED INAPPROPRIATE COUNTS IN THE VENTRICULAR FIBRILLATION (VF) ZONE. A REVISION PROCEDURE WAS TO BE PERFORMED IN THE NEAR FUTURE TO IMPLANT A NEW LEAD. THE RIGHT VENTRICULAR (RV) LEAD REMAINS IN SERVICE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    APPROXIMATELY THREE AND A HALF MONTHS LATER, A REVISION PROCEDURE WAS PERFORMED DUE TO HIGH PACING IMPEDANCES AND NOISE. DURING THE PROCEDURE THE INTEGRITY TEST SHOWED THE FOLLOWING SHOCK IMPEDANCES: 47 OHMS (1,7 J SHOCK), 46 OHMS (17 J), 47 OHMS (41 J). THE DECISION WAS MADE TO ABANDONED THE PACE/SENSE PORTION OF THIS LEAD AND A NEW LEAD WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145097 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention