BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211091 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08152
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    March 25, 2013
    Report Date
    August 1, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT AN INVASIVE PROCEDURE WAS PERFORMED. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS NOTED THAT WITH THE PREVIOUS DEVICE, SHOCK IMPEDANCE MEASUREMENTS WERE GREATER THAN 125 OHMS, HOWEVER, WITH THE REPLACEMENT DEVICE, SHOCK IMPEDANCE MEASUREMENTS WERE GREATER THAN 200 OHMS AND INCREASED THRESHOLD MEASUREMENTS WERE OBSERVED. AN ISSUE WAS SUSPECTED WITH THE DISTAL COIL OF THE LEAD. THE LEAD WAS INITIALLY SURGICALLY ABANDONED AND REPLACED.

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SHOCK IMPEDANCE MEASUREMENTS FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD HAD TRENDED UP FROM 42 OHMS AT IMPLANT TO 93 OHMS TO A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A DEVICE AND LEAD REPLACEMENT PROCEDURE WAS PLANNED FOR A DATE IN THE FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311077 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R 0184| T165| 4470