BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2781066 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13150
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 20, 2012
    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

    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 THIS DEPENDENT PATIENT RETURNED TO THE CLINIC FOR A ROUTINE DEVICE CHECK SHORTLY AFTER IMPLANT. UPON INTERROGATION THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) NOTED A LOSS OF CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. HOWEVER, THE PATIENT HAD NO SYMPTOMS. THE PATIENT'S NON-BOSTON SCIENTIFIC LEFT VENTRICULAR (LV) LEAD WAS PROGRAMMED HIGH ENOUGH TO CAPTURE AND PACE. DUE TO THE PATIENT'S ANATOMY THIS RV LEAD COULD NOT BE REPOSITIONED AND IT WAS SURGICALLY ABANDONED. A PREVIOUSLY ABANDONED RV LEAD WAS UTILIZED. DIAPHRAGMATIC STIMULATION WAS ALSO NOTED DUE TO THE NON-BOSTON SCIENTIFIC LV LEAD. NO OTHER PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R 1291| 0293| 4470| 4471| 4480| MISMATCH| N140| 4479