BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET TIP

    MDR report key: 5400687 · Received January 30, 2016

    Report

    Report Number
    2124215-2016-01897
    Event Type
    Malfunction
    Date Received
    January 30, 2016
    Date of Event
    June 11, 1999
    Report Date
    June 11, 1999
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THREE TYPES OF INSULATION DAMAGE WERE NOTED. VISUAL INSPECTION OF THE LEAD NOTED BOTH THE INTERNAL AND THE EXTERNAL INSULATION WAS ABRADED THROUGH TO THE CONDUCTOR COIL 195-275MM AND 290-300MM FROM THE TERMINAL PIN. ANALYSIS CONFIRMED THE INNER CONDUCTOR COIL WAS FRACTURED IN THIS AREA. MICROSCOPIC EVALUATION INDICATED THAT THE INSULATION DAMAGE WAS CAUSED BY LOCALIZED COMPRESSIVE STRESS ON THE INSULATION SURFACE. DUE TO THE LOCATION AND THE TYPE OF DAMAGE EXHIBITED, IT WAS CONCLUDED THAT THE DAMAGE WAS CAUSED BY LEAD ENTRAPMENT IN THE CLAVICLE-FIRST RIB REGION. VISUAL INSPECTION ALSO REVEALED INSULATION DAMAGE 390-393MM FROM THE TERMINAL PIN. THIS TYPE OF DAMAGE IS CONSISTENT WITH REPEATED STRESS OVER TIME. IN THIS CASE, WE BELIEVE THE STRESS WAS THE RESULT OF LEAD CONTACT WITH A CALCIFIED HEART VALVE. INSULATION DAMAGE WAS ALSO NOTED APPROXIMATELY 490-493MM FROM THE TERMINAL PIN. AGAIN, THIS TYPE OF DAMAGE IS CONSISTENT WITH REPEATED STRESS OVER TIME. WE BELIEVE THE STRESS WAS THE RESULT OF LEAD CONTACT WITH ANOTHER LEAD. A SUMMARY REPORT WAS PREVIOUSLY SUBMITTED TO FDA ON 08/01/1999; HOWEVER DUE TO EMDR SUBMISSION ISSUE RELATED TO THE SUPPLEMENTAL REPORT, THIS IS BEING FILED AGAIN AS AN INITIAL REPORT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED LOW PACE IMPEDANCE AFTER THE PATIENT FELL. IT WAS REPORTED THAT THE FALL DAMAGED THE LEAD. THE PHYSICIAN PERFORMED A LEAD REVISION. SIXTEEN YEARS LATER THIS LEAD WAS EXPLANTED DUE TO INFECTION. THE LEAD WAS RETURNED FOR ANALYSIS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59201 SWEET TIP IMPLANTABLE LEAD NVN HISTORICAL PUERTO RICO 4269

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR