BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2051763 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03677
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    January 14, 2011
    Report Date
    April 17, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN MADE. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    JOURNAL CITATION: ELLENBOGEN, K. A., B. D. GUNDERSON, ET AL. (2013). "PERFORMANCE OF ICD LEAD INTEGRITY ALERT TO ASSIST IN THE CLINICAL DIAGNOSIS OF ICD LEAD FAILURES: ANALYSIS OF DIFFERENT ICD LEADS." CIRC ARRHYTHM ELECTROPHYSIOL: EPUB BEFORE PRINT. INDIVIDUAL COMPLAINT RECORDS WERE CREATED FOR EACH OBSERVATION AS NEEDED AND REPORTS FILED AS REQUIRED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PACE/SENSE PORTION OF THE RV LEAD WAS SURGICALLY ABANDONED. ANOTHER MANUFACTURER'S PACE/SENSE RV LEAD WAS SUCCESSFULLY IMPLANTED. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    RECENTLY A JOURNAL ARTICLE WAS REVIEWED THAT INDICATED A PERFORMANCE ISSUE CONSISTENT WITH WHAT HAD BEEN PREVIOUSLY REPORTED. HOWEVER, WITHIN THE HISTORICAL DATA AN EARLIER EVENT DATE WAS PROVIDED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS EXHIBITING HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 3,000 OHMS. THERE WAS SUSPICION OF A CONDUCTOR FRACTURE. THE PATIENT PLANNED TO BE BROUGHT INTO THE CLINIC FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 0158| 4087| 4537| H170