BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2041695 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01030
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 13, 2011
    Report Date
    March 22, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    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 LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND 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.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS DEFIBRILLATION LEAD EXHIBITED HIGH PACING THRESHOLDS AND OUT OF RANGE RIGHT VENTRICULAR (RV) IMPEDANCES OF GREATER THAN 2,000 OHMS ONE DAY POST-OP. IT WAS NOTED THAT A MICRO-PERFORATION WAS SUSPECTED; THEREFORE, A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS EXPLANTED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. AFTER THE IMPLANT OF THE NEW LEAD, AN ECHOCARDIOGRAM WAS PERFORMED. THERE WAS NO EVIDENCE OF PERFORATION OR CARDIAC EFFUSION PRESENT; THEREFORE, A MICRO-DISLODGEMENT OF THE ORIGINAL LEAD WAS LATER SUSPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THIS LEAD WAS LATER RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention E110| 0175| 0185| 4470