BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3905392 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10761
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 26, 2014
    Report Date
    June 18, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION OF THE LEAD FOUND THAT THE HELIX MECHANISM WAS EXTENDED AND DRIED BLOOD WAS NOTED IN THE HELIX HOUSING AND THERE WAS TISSUE ENTWINED IN THE HELIX. A LABORATORY TECHNICIAN TESTED THE HELIX MECHANISM AND FOUND IT WAS NONFUNCTIONAL, MOST LIKELY DUE TO THE BLOOD INFILTRATION AND TISSUE. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS ABLE TO CONFIRM THE NON-FUNCTIONING HELIX; HOWEVER, ANALYSIS WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS OF OUT OF RANGE PACING THRESHOLD MEASUREMENTS AND THE PERFORATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS RIGHT VENTRICULAR (RV) LEAD, THE PACING THRESHOLD MEASUREMENTS WERE OUT OF RANGE SO THE PHYSICIAN WAS GOING TO REPOSITION THE LEAD; HOWEVER, THE HELIX COULD NOT BE RETRACTED. IT WAS THEN DISCOVERED THAT THE PATIENT HAD A PERICARDIAL EFFUSION AS A RESULT OF A PERFORATION. SURGICAL INTERVENTION WAS PERFORMED TO TREAT THE PATIENT'S INJURY. THE RV LEAD WAS EXPLANTED AND WILL BE RETURNED FOR LABORATORY ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED AND THE PATIENT IS NOW IN STABLE CONDITION.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382323 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4088

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4088