BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1771442 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12512
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 7, 2010
    Report Date
    June 7, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    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

    THE PATIENT WAS BROUGHT IN CLINIC TO CHECK THE SYSTEM. THE PHYSICIAN HAS ELECTED TO MONITOR THE SITUATION AT THIS TIME, AND WILL BRING THE PATIENT BACK FOR CLINICAL FOLLOW-UP IN SIX MONTHS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME, AND CURRENT RECORDS SUGGEST THAT THIS DEVICE AND RV LEAD REMAIN IMPLANTED AND IN SERVICE. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SINGLE LOW SHOCK IMPEDANCE MEASUREMENT OF LESS THAN 20 OHMS, TRIGGERING A LATITUDE RED ALERT. HISTORICAL SHOCK IMPEDANCE MEASUREMENTS HAD REPORTEDLY BEEN IN THE 45 OHM RANGE. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS OBSERVATION.

    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 73 YR Life Threatening 0185| 4470| E110