BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3953805 · Received July 23, 2014

    Report

    Report Number
    2124215-2014-14220
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH THIS NEWLY IMPLANTED RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING THRESHOLDS GREATER THAN 2,000 OHMS, HIGH PACING THRESHOLDS AND LOW R-WAVES ALONG WITH NOISE BEING OVERSENSED DURING PRE-DISCHARGE CHECK AFTER LEAD REVISION. ADDITIONAL INFORMATION INDICATED THAT THE PATIENT WAS RE-EVALUATED FOR POSSIBLE CAUSES, HOWEVER THIS NEW RV LEAD WAS FIRMLY IN THE HEADER. THE LEAD WAS DISCONNECTED AND CHECKED THROUGH A PACING SYSTEM ANALYZER (PSA) WITH MEASUREMENTS NOTED IN NORMAL RANGE. FURTHER, IT WAS DECIDED TO REPLACE THE DEVICE. THE CAUSE OF THESE OBSERVATIONS WAS UNDETERMINED AT THIS TIME. THE ICD WAS EXPLANTED AND NO LONGER IN SERVICE WHILE THE RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431637 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R 1860| E102| E141| 0128| 0181