BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211548 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09630
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THIS LEAD WAS SURGICALLY ABANDONED, NO RETURN OF PRODUCT IS INTENDED. 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 REMOTE MONITORING OF THIS RIGHT VENTRICULAR LEAD REVEALED A DECREASED IMPEDANCE MEASUREMENT. IN ADDITION, IT WAS NOTED SENSING FROM THE ATRIUM AND THE VENTRICLE THAT RESULTED IN INAPPROPRIATE VENTRICULAR FIBRILLATION (VF) DETECTION, HOWEVER NO SHOCK WAS DELIVERED AS A RESULT OF THIS ISSUE. AN X-RAY WAS PERFORMED REVEALING THIS LEAD WAS DISLODGED. IN ADDITION, THE LEAD WAS RUBBING ON THE ATRIAL LEAD. A REVISION PROCEDURE WAS PERFORMED. DIFFICULTY WAS ENCOUNTERED REMOVING THIS LEAD, THEREFORE THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. REPORTEDLY, THE PATIENT WITH THIS LEAD HAD RECEIVED PHYSIOTHERAPY TREATMENT RECENTLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310275 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R