BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3790177 · Received May 5, 2014

    Report

    Report Number
    2124215-2014-05589
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    October 22, 2011
    Report Date
    April 16, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    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). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, AN EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION REVEALED CALCIFIED BODY FLUID COVERING OVER THE DISTAL AND PROXIMAL SHOCKING COILS WHICH COULD AFFECT THE IMPEDANCE MEASUREMENTS. X-RAY EXAMINATION OBSERVED INDUCED-FRACTURE IN ONE OF THE THREE RS-COIL¿S FILAR MOST LIKELY DURING THE EXTRACTION. NO NON-INDUCED-FRACTURE IN CONDUCTORS WAS OBSERVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED INDICATING THAT THIS RV LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WERE EXPLANTED AND REPLACED. THE PHYSICIAN THOUGHT THERE WAS A LEAD FRACTURE IN THE MIDDLE PORTION OF THE LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT¿S SYSTEM EXHIBITED HIGH OUT-OF-RANGE (OOR) RIGHT VENTRICULAR (RV) SHOCK LEAD IMPEDANCE MEASUREMENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED FACTORS AFFECTING THIS OBSERVATION. ALL OTHER LEAD MEASUREMENTS WERE GOOD. THE PATIENT WILL CONTINUE TO BE MONITORED. THIS SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267160 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR T175| 0185| E102