BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2151530 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-07017
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A SURGICAL INTERVENTION WAS PERFORMED, WHICH DETERMINED THAT THERE WAS A LOOSE SETSCREW AND THAT THE HIGH VOLTAGE CONNECTORS WERE REVERSED IN THE DEVICE HEADER. SINCE THE PATIENT HAS CHRONIC ATRIAL FIBRILLATION, DEFIBRILATION THRESHOLD TESTING WAS NOT DONE, BUT A COMMANDED SHOCK WAS DONE TO TEST THE DEVICE SYSTEM INTEGRITY. SHOCK IMPEDANCE WAS DETERMINED TO BE WITHIN NORMAL LIMITS AT 38 OHMS SHOCK IMPEDANCE. THE LOCAL AREA SALES REPRESENTATIVE ALSO NOTED SOME OVERSENSING ON THE VENTRICULAR CHANNEL OF INTRINISC ATRIAL ACTIVITY FOR A FEW BEATS THAT THEN WENT AWAY. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS DEFIBRILLATION LEAD IN ASSOCIATION WITH THE IMPLANTABLE CARIOVERTER DEFIBRILLATOR (ICD) DID EXHIBIT GREATER THAN 125 OHMS SHOCK IMPEDANCE VALUE. THE PATIENT HAD PRESENTED TO THE EMERGENCY ROOM, COMPLAINING OF A WEIRD FEELING LIKE A SMALL SHOCK. TO DATE, THIS MEDICAL DEVICE REMAINS ACTIVELY IN SERVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

    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 83 YR Required Intervention 4136| 0185| E110