BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173175 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10748
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE LEAD HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, CRM FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF FURTHER INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A REVISION PROCEDURE TO REPLACE THE LEFT VENTRICULAR (LV) LEAD, THE PATIENT WITH THIS IMPLANTABLE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXPERIENCED DIAPHRAGMATIC STIMULATION AFTER DISCONNECTING THE LV LEAD. THIS WAS ALSO CONFIRMED WITH THROUGH TESTING WITH THE PACING SYSTEM ANALYZER (PSA). THERE WAS A SUSPECTED CONDUCTOR FRACTURE AND INSULATION DAMAGE CLOSE TO THE POCKET AREA. FLUOROSCOPY CONFIRMED BREAKS IN THE LV AND RV LEADS. HOWEVER, THE RV LEAD MEASUREMENTS WERE WITHIN NORMAL RANGE WITH A PACING IMPEDANCE MEASUREMENT OF 480 OHMS, INTRINSIC SENSING AT 17 MV AND PACING THRESHOLDS AT 0.8 V. THE LEADS WERE EXTRACTED AND SUCCESSFULLY REPLACED. THE PATIENT WAS NOT PACEMAKER DEPENDENT AND THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening| R 4525| H175| H170| 4087| 0185| 4136