BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1875164 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18269
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 3, 2010
    Report Date
    April 17, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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. JOURNAL REFERENCE: 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

    TO DATE, INFORMATION SUGGESTS THAT THIS RV LEAD REMAINS ACTIVELY IN SERVICE. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A PHYSICIAN CONDUCTED ANALYSIS OF PRODUCT PERFORMANCE DATA AS PART OF RESEARCH FOR A JOURNAL ARTICLE. DURING THE ANALYSIS AND RESEARCH, DATA WAS REPORTED THAT LEAD INTERFERENCE WAS PREVIOUSLY OBSERVED DURING REPAIR OF THE PATIENT'S LEFT BRACHIAL ARTERY, AND IT WAS ACTIVELY DURING THE SURGERY. HOWEVER, THERE WAS A QUESTION ON WHETHER THE PROCEDURE CAUSED SOME CHANGES IN THE LEAD. REPROGRAMMING TO INCREASE THE NUMBER OF INTERVALS FOR DETECTION WAS PERFORMED. FURTHER INFORMATION WAS PROVIDED BY THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE THAT THREE ELECTROGRAMS (EGMS) WITH NOISE HAD BEEN NOTED AT THIS TIME; HOWEVER, THE SOURCE WAS NOT IDENTIFIED. REPORTEDLY, THERE WERE NO CHANGES MADE AND NO OTHER WERE NOTED. THIS LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD HAD EXHIBITED SOME NOISE AND TONES FOR OUT-OF-RANGE IMPEDANCE MEASUREMENT IN ASSOCIATION WITH THE COMPETITOR'S DEVICE. NO FURTHER INFORMATION WAS MADE AVAILABLE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0147

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 4574| 0147| T125| MISMATCH