BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1950970 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22967
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 15, 2007
    Report Date
    November 19, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION IN (B)(6) 2007 THAT THIS LOCAL SALES REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS CHRONIC IMPLANTABLE TRANSVENOUS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED A PACING IMPEDANCE MEASUREMENT OF 1627 OHMS LAST YEAR. THE RV PACING IMPEDANCE MEASUREMENT REMAINED STABLE AT 1942 OHMS. ADDITIONALLY, THE RV SHOCK IMPEDANCE MEASUREMENTS HAD REMAINED RELATIVELY STABLE. THE PHYSICIAN WAS CONSIDERING PLACEMENT OF A SEPARATE PACE/SENSE LEAD, HOWEVER, A ENTIRE DEFIBRILLATION LEAD EXTRACTION WAS NOT RULED OUT. BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL SALES REPRESENTATIVE THAT THIS PATIENT'S SITUATION REMAINS UNCHANGED. THE PHYSICIAN AND PATIENT WERE STILL CONSIDERING THE OPTIONS. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION IN (B)(6) 2010 THAT THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY. THE RV PACE/SENSE PORTION OF THE RV DEFIBRILLATION LEAD WAS SURGICALLY CAPPED DUE TO A GREATER THAN 3000 OHMS PACING IMPEDANCE MEASUREMENT. A SEPARATE RV PACE/SENSE RV LEAD WAS IMPLANTED. THE SHOCK PORTION OF THE RV DEFIBRILLATION LEAD REMAINS IN-SERVICE. THE RV PACING IMPEDANCE MEASUREMENT WITH THE REPLACEMENT LEAD WAS 575 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R 0148| T135