BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4131634 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14275
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 25, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LEAD HAS BEEN RETURNED. BOSTON SCIENTIFIC HAS CONCLUDED IT IS UNLIKELY THAT LEAD CHARACTERISTICS CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS, LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS LESS THAN 20 OHMS AND DECREASED R-WAVE MEASUREMENTS. ADDITIONALLY, RV UNDERSENSING AND OVERSENSING WAS OBSERVED THAT RESULTED IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCK THERAPY. THE LEAD WAS OBSERVED TO HAVE DISLODGED. IT WAS REPORTED THAT THE PATIENT SUFFERED FROM TWIDDLER'S SYNDROME. AN INVASIVE PROCEDURE WAS PERFORMED. THE RV LEAD WAS EXPLANTED AND REPLACED AND THIS ICD REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613105 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R 0293| E140