BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1771303 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12384
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WAS SURGICALLY ABANDONED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD DISPLAYED NOISE WITH TEMPORARY PACING INHIBITION ON THE PACING CHANNEL. INITIAL VENTRICULAR FIBRILLATION RECOGNITION WAS NOTED, HOWEVER THERE WERE NO INAPPROPRIATE SHOCKS. PACING INHIBITION WAS GREATER THAN TWO SECONDS, HOWEVER NO ASYSTOLE OCCURRED AS THE PATIENT HAS A VENTRICULAR ESCAPE INTRINSIC RHYTHM. THE PATIENT WITH THIS LEAD IS PACEMAKER DEPENDENT AND HAS EXPERIENCED EPISODES OF DIZZINESS. A REVISION PROCEDURE WAS PERFORMED, THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED. THE DEVICE WAS ALSO REMOVED AND REPLACED. THERE WAS NO ALLEGATION AGAINST THE DEVICE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 Other H190| 0184