BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4131509 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14272
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 DETECTED NOISE, RESULTING IN INAPPROPRIATE SENSING OF VENTRICULAR FIBRILLATION (VF) WAS OBSERVED. THE DEFIBRILLATION PORTION OF THIS LEAD WAS PROGRAMMED OFF. IT WAS UNKNOWN IF INAPPROPRIATE THERAPY WAS DELIVERED. PACING FUNCTION AND OUTPUT WAS NOT AFFECTED. A REVISION PROCEDURE WAS PERFORMED AND THE RV LEAD WAS PARTIALLY SURGICALLY ABANDONED, WITH THE PACING THERAPY PROGRAMMED ON. A CONDUCTOR FRACTURE WAS SUSPECTED, HOWEVER, WAS NOT CONFIRMED WITH FLUOROSCOPY. THE DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611860 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R N164| 0184| H175| 4513| 0185| 4054| N118