BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2162524 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07522
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 20, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A RECENT ROUTINE CHANGE OUT PROCEDURE, ONCE THE RIGHT VENTRICULAR (RV) LEAD WAS REMOVED FROM THE HEADER OF THE CHRONIC DEVICE, THE PATIENT WENT ASYSTOLIC AND FLAT LINED. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE (SR) ATTEMPTED CHANGING THE PROGRAMMING TO DOO AND THAT DID NOT ALLEVIATE THE ASYSTOLE. THE RIGHT ATRIAL AND LEFT VENTRICULAR LEAD WERE THEN IMPLANTED AND ALL MEASUREMENTS WERE BACK TO NORMAL, AND NORMAL PACING RESUMED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND STATED THAT THEY BELIEVE THAT SINCE THE RV PORT OF THE CHRONIC DEVICE WAS OPEN, THE DEVICE WAS OVERSENSING NOISE AND INHIBITING PACING AS A RESULT OF THAT NOISE. THE REST OF THE IMPLANT WENT WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0174

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| O 0174| 4086| H210| 4538| 1280| 4285| N119| 4543| 4047