BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPORE

    MDR report key: 1851780 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14177
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 8, 2010
    Report Date
    August 17, 2010
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD IS EXPECTED TO BE RETURNED TO FOR ANALYSIS. THIS REPORT WILL BE UPDATED AND RESUBMITTED ONCE THE LEAD IS RETURNED AND ANALYZED, OR IF OTHER INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    A 17 CM SEGMENT OF THE PROXIMAL PORTION OF THE LEAD WAS RETURNED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION OF THE LEAD CONFIRMED THE TERMINAL PIN HAD SEPARATED ABOUT 1 MM FROM THE TERMINAL RING. SLIGHT FOLDING BACK OF SOME OF THE SEAL RING WAS OBSERVED. VOIDS AND AIR BUBBLES WERE SEEN IN THE MEDICAL ADHESIVE UNDER THE TERMINAL RING. NO SIGNS OF EXCESSIVE FORCE OR TOOL DAMAGE WERE OBSERVED. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATION OF POOR MEASUREMENTS AND LOSS OF CAPTURE. THE REPORTED TERMINAL ASSEMBLY SEPARATION WAS CONFIRMED BY VISUAL INSPECTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT, DURING A DEVICE REPLACEMENT PROCEDURE, THIS LEAD WAS REMOVED FROM THE EXPLANTED DEVICE LEAD PORT WITH NO RESISTANCE. LEAD MEASUREMENTS TAKEN WITH A PACING SYSTEM ANALYZER (PSA) WERE ACCEPTABLE. THE LEAD WAS INSERTED INTO THE REPLACEMENT DEVICE LEAD PORT AND THE SETSCREW WAS SEATED. THE LEAD WAS GENTLY PULLED TO TEST THE CONNECTION. WHEN THE LEAD WAS PULLED, THE RING ELECTRODE BECAME SEPARATED FROM THE TERMINAL PIN. SEVERAL ATTEMPTS WERE REQUIRED TO REMOVE THE TERMINAL PIN FROM THE DEVICE LEAD PORT. TESTING WITH THE PSA NOTED LOSS OF CAPTURE IN BOTH BIPOLAR AND UNIPOLAR PACING MODES. THE LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPORE IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 432-02

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR 432-02| 262-16