BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS

    MDR report key: 1852864 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-15243
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE CLINICAL OBSERVATION. THERE IS NO FURTHER INFORMATION AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE TO OUR COMPANY, THIS EVENT WOULD BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT SAFETY SWITCH TRIPPED FOR THE RIGHT ATRIAL (RA) LEAD DUE TO LOW IMPEDANCE MEASUREMENTS. IMPEDANCE MEASUREMENTS IN BIPOLAR MODE WERE 100 OHMS AND 220 OHMS IN UNIPOLAR. IT WAS ALSO NOTED THAT THE RA LEAD WAS OVERSENSING NOISE. THE CHEST X-RAY WAS NOT CONCLUSIVE, SO THE PHYSICIAN OPTED TO KEEP THE RA LEAD PROGRAMMED TO UNIPOLAR. TWO MONTHS LATER RIGHT VENTRICULAR (RV) OVERSENSING WAS NOTED, SO THE RA LEAD WAS RE-TESTED AND THE IMPEDANCE MEASUREMENT IN BIPOLAR CONFIGURATION WAS GREATER THAN 2300 OHMS. ANOTHER X-RAY WAS TAKEN, HOWEVER NO SIGN OF A RA LEAD FRACTURE WAS NOTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ADVISED THE SALES REPRESENTATIVE THAT THE RA LEAD HAS A COAXIAL DESIGN, SO THE OUTER INSULATION DAMAGE MAY NOW BE AFFECTING THE OUTER COIL. THE RA LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENOUS IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4271

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R S602| 1270| 4285| 4271| 4456