BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1950771 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22617
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 18, 2010
    Report Date
    December 6, 2010
    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

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT WAS BROUGHT IN AND THE NOISE WAS UNABLE TO REPRODUCED WITH POCKET MANIPULATIONS. A REVISION PROCEDURE TOOK PLACE AND THE CONNECTIONS WERE VERIFIED. THE PACE/SENSE PORTION OF THE RV LEAD WAS SURGICALLY ABANDONED AND A NEW PACE/SENSE LEAD WAS IMPLANTED. THE CHRONIC RV LEAD REMAINS IN SERVICE FOR DEFIBRILLATION. A HIGH VOLTAGE SHOCK WAS DELIVERED AND ALL MEASUREMENTS WERE WITHIN NORMAL RANGE. ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN MADE. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WERE EXHIBITING NOISE ON THE RATE/SENSE AND SHOCK CHANNEL. THIS PATIENT IS PACEMAKER DEPENDANT AND PACING WAS INHIBITED FOR APPROXIMATELY 5 SECONDS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT PLANNED TO BE SENT TO THEIR DEVICE FOLLOWING PHYSICIAN FOR A PROBABLE LEAD REPLACEMENT. THERE WERE ALSO SOME DIVERTED EPISODES DUE TO THE INAPPROPRIATE SENSING, HOWEVER NO SHOCKS HAD BEEN DELIVERED. THE NOISE WAS ABLE TO BE REPRODUCED WITH ARM MOVEMENTS. THERE HAD BEEN NO CHANGE IN IMPEDANCES, THRESHOLDS, OR SENSING MEASUREMENTS.

    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 84 YR Required Intervention 0185| MISMATCH| 4469| (B)(4)| 4542| H210| 1290