BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3971316 · Received July 31, 2014

    Report

    Report Number
    2124215-2014-14797
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    June 25, 2014
    Report Date
    March 27, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN EPISODE OF NOISE WITH OVERSENSING LEADING TO INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP). THE NOISE STOPPED AFTER DEVICE DELIVERED QUICK CONVERT. THERE WAS NO NOISE OBSERVED DURING A CHECK OF THRESHOLDS OR WHEN DOING ISOMETRICS. THERE WAS ALSO HIGH OUT OF RANGE PACING IMPEDANCE RECORDED IN THE DEVICE HISTORY. THE PATIENT IS NON COMPLIANT AND HAS NOT BEEN CHECKED IN YEARS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS PRESENTED FOR AN UPGRADE DEVICE PROCEDURE. THE DEVICE WAS EXPLANTED AND REPLACED. THE RV LEAD REMAINS ACTIVELY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING HIGH OUT OF RANGE PACE IMPEDANCE CONTINUES, FLUCTUATING BETWEEN 516 OHMS AND > 2000 OHMS FOR THE PAST YEAR. ALL OTHER MEASUREMENTS ARE THE SAME. STILL UNABLE TO REPRODUCE NOISE. THE FIELD REPRESENTATIVE WILL DISCUSS THE SITUATION AND OPTIONS WITH THE PHYSICIAN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446941 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R E102| 0185