BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 3760917 · Received April 21, 2014

    Report

    Report Number
    2124215-2014-08769
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    January 26, 2014
    Report Date
    April 30, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND LEAD WILL CONTINUE TO BE MONITORED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. ONLY THREE TERMINAL-END LEGS WERE RETURNED; EACH WERE CUT APPROXIMATELY 8 CENTIMETERS FROM THE TERMINAL END. TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INNER INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EMITTED BEEPING TONES. UPON INTERROGATION THE IMPLANTABLE DEFIBRILLATION LEAD HAD GOOD MEASUREMENTS, HOWEVER ONE SHOCK IMPEDANCE MEASUREMENT OF 0 OHMS WAS NOTED IN THE DAILY MEASUREMENTS. THERE WAS NO NOISE IN ANY OF THE STORED ELECTROGRAMS (EGMS). ISOMETRICS WAS ALSO PERFORMED AND NOISE WAS NOT PRODUCED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED INDICATING THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS RETURNED AND A DEVICE EVALUATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239384 ENDOTAK RELIANCE G IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0184 132312

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 4086| 4543| 4549| H177| N141| 0184| 2188