BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWEET TIP BIPOLAR LEAD

    MDR report key: 94383 · Received March 6, 1997

    Report

    Report Number
    2124215-1997-01169
    Event Type
    Injury
    Date Received
    March 6, 1997
    Date of Event
    February 5, 1997
    Report Date
    December 4, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT A PATIENT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), A TRANSVENOUS DEFIBRILLATION LEAD AND A BIPOLAR ATRIAL LEAD EXPERIENCED DEVICE MIGRATION AND ATRIAL LEAD DISLODGEMENT. AN INVASIVE PROCEDURE WAS PERFORMED 12 DAYS POST IMPLANT AND THE BIPOLAR LEAD WAS REPOSITIONED. THE ICD, A VENTAK AV (MODEL 1810, SERIAL NUMBER 3000037) WAS REPOSITONED. THE ICD IS NOT MARKET RELEASED IN THE UNITED STATES. CPI LEARNED ON JANUARY 27,1997, THAT THE ATRIAL LEAD IMPEDANCE AND THRESHOLD MEASUREMENTS (THROUGH ICD DIAGNOSTICS) ARE UNACCEPTABLE AND ANOTHER INVASIVE PROCEDURE IS BEING CONSIDERED. X-RAY SHOWS DISLOCATION OF THE ATRIAL LEAD. THE ICD WAS REPROGRAMMED FROM THE DDD MODE TO THE VDD MODE. THIS REPORT WILL BE UPDATED WHEN FURTHER INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET TIP BIPOLAR LEAD Implant BIPOLAR LEAD DXY CARDIAC PACEMAKERS 4269 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention THE DEVICE 0125/211136 WAS IMPLANTED 11-SEP-1996| THE DEVICE 1810/300037 WAS IMPLANTED 11-SEP-1996| THE DEVICE 1763/802229 WAS IMPLANTED 11-FEB-1997