BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3904348 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09683
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    March 23, 2014
    Report Date
    April 4, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 RIGHT VENTRICULAR (RV) LEAD PRESENTED WITH NOISE ON BOTH THE VENTRICULAR AND SHOCK CHANNELS THAT WAS BEING OVERSENSED AND LED TO AN INAPPROPRIATE SHOCK. IN ADDITION, THE PACING IMPEDANCE MEASUREMENTS HAD DECREASED TO 270 OHMS. A LEAD REVISION WAS PERFORMED AND THIS RV LEAD WAS SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383770 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L| R E110| 0185| 4087