BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4131692 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15575
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    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

    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 DEVICE AND LEADS EXHIBITED LOSS OF CAPTURE (LOC) THAT RESULTED IN SYNCOPE. THE PATIENT HAS HEALTH ISSUES, IS ON DIALYSIS AND IS IN CHRONIC ATRIAL FIBRILLATION AND PACING DEPENDENT. THE DEVICE WAS PROGRAMMED TO MAXIMUM OUTPUTS AND CAPTURE WAS THEN CONSISTENT. THE RIGHT VENTRICULAR (RV) LEADHAS A HISTORY OF HIGH THRESHOLDS AND THE PHYSICIAN ELECTED TO TURN DOWN THE RIGHT VENTRICULAR (RV) LEAD OUTPUT TO SAVE BATTERY LIFE AND PRIMARILY USE THE LEFT VENTRICULAR (LV) LEAD FOR PACING. THIS IS CONSIDERED OFF-LABEL USE AND BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE RISKS INVOLVED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612145 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R N118| A135| 5054| 0158| 4525| 5568| MISMATCH