BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2042411 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01178
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 11, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. THE COMPLETE LEAD WAS RETURNED AND THE HELIX WAS FOUND TO PHYSICIALLY BE WITHIN SPECIFICATIONS. FURTHER TESTING CONFIRMED THAT DIRECT CURRENT TESTING PASSED ON ALL LEAD CHANNELS. NO FURTHER TESTING WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE SYSTEM EXHIBITED A FLAT SHOCK MORPHOLOGY WITH NOISE PRESENT. TECHNICAL SERVICES DISCUSSED OBSERVATIONS AND RECOMMENDATIONS. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE REPORTED THAT CAPTURE COULD NOT BE VERIFIED BASED ON A SURFACE ELECTROGRAM. ADDITIONALLY, NO SENSING WAS OBSERVED. A MICRO-DISLODGMENT OF THE RIGHT VENTRICULAR (RV) LEAD WAS SUSPECTED AND A LEAD REVISION PROCEDURE WAS SCHEDULED. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND THE DEVICE AND RV LEAD WERE EXPLANTED AND REPLACED WITHOUT COMPLICATION. THE RV LEAD WAS RETURNED FOR RELABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0187

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR 0187| 0158| E102