BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043581 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02302
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 THAT DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE, THE SHOCK IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD WITH THE CHRONIC DEVICE WAS 55 OHMS. AFTER CONNECTING THE RV LEAD TO THE NEW DEVICE, THE MEASUREMENTS WERE GREATER THAN 200 OHMS. THE NEW DEVICE WAS RECONNECTED AFTER CLEANING ALL CONNECTORS AND THE MEASUREMENT REMAINED GREATER THAN 200 OHMS. THE LEAD WAS RECONNECTED TO THE CHRONIC DEVICE AND NOTED A MEASUREMENT OF 55 OHMS. THE DEVICE WAS CONNECTED TO THE NEW DEVICE AND MEASUREMENTS GREATER THAN 200 OHMS PERSISTED. SINGLE COIL MEASUREMENTS WERE 89 OHMS, WHILE DUAL COIL MEASUREMENTS WERE GREATER THAN 200 OHMS. AS A RESULT, IT WAS SUSPECTED THAT THE PROXIMAL COIL WAS THE CAUSE OF THE OUT OF RANGE MEASUREMENTS. FLUOROSCOPY WAS USED AND NO LEAD DEFECTS WERE NOTED. THEREFORE, IT WAS DECIDED TO PROGRAM THE LEAD TO SINGLE COIL CONFIGURATION AND MONITOR APPROPRIATELY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147010 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1