BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELUTE

    MDR report key: 1970218 · Received January 25, 2011

    Report

    Report Number
    2124215-2011-01031
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 8, 2007
    Report Date
    August 3, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED RETURNED IN TWO SEGMENTS, SEVERED 25.5 CENTIMETERS (CM) FROM THE TERMINAL PIN. PORTIONS OF THE EXTRACTING STYLET REMAINED STUCK IN THE DISTAL SEGMENT OF THE LEAD. THE COILS WERE STRETCHED AND INSULATION WAS TORN APART AT THE DISTAL REGION OF THE LEAD, LIKELY CAUSED BY THE EXPLANT PROCEDURE. AN X-RAY WAS PERFORMED AND NO EVIDENCE OF A FRACTURE WAS FOUND. RESISTANCE TESTING WAS PERFORMED TO ASSESS THE LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGH THIS TEST WERE WITHIN NORMAL LIMITS. LABORATORY ANALYSIS COULD NOT CONFIRM THE CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THE ABANDONED LEAD WILL NOT BE RETURNED FOR ANALYSIS THEREFORE BOSTON SCIENTIFIC CANNOT CONFIRM THIS CLINICAL OBSERVATION. 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

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS LEAD WAS EXPLANTED DURING A RECENT DEVICE REPLACEMENT PROCEDURE. THE LEAD WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ELECTIVE DEVICE REPLACEMENT PROCEDURE, THIS ATRIAL LEAD WAS ABANDONED SURGICALLY DUE TO POOR R-WAVE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. FOUR YEARS LATER, OUR COMPANY RECEIVED INFORMATION FROM THE PATIENT THAT ONE OF HER LEADS HAD FRACTURED. AGAIN, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4285

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)