BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053579 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05049
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY IT WAS NOTED THAT THE COMPLETE LEAD WAS RETURNED. VISUAL INSPECTION REVEALED THA TTHE LEAD BODY WASS TWISTED. THIS DAMAGE APPEARED TO BE INDUCED DAMAGE FROM TRYING TO RETRACT THE HELIX. THE LEAD WAS SUBJECT TO DIRECT CURRENT RESISTANCE TESTING AND PASSED ON ALL PATHS, VERIFYING THE ELECTRICAL PERFORMANCE WAS INTACT. NO FURTHER TESTING WAS PERFORMED. ANALYSIS COULD NOT CONFIRM THE CLINICAL ALLEGATIONS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT WHEN ATTACHED TO THE DEVICE, EVEN AFTER RECONNECTION. IT WAS ALSO NOTED THAT THE ELECTROGRAM APPEARED ABNORMAL WITH NOISE AND A FLAT SHOCK CHANNEL. SUBSEQUENTLY THE PHYSICIAN ATTEMPTED A NEW LEAD WITH NO OTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156489 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 4470| E142| 0293| 0296