BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040725 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-04018
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 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 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 DURING A FOLLOW UP VISIT, THIS RIGHT VENTRICULAR LEAD DISPLAYED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. THRESHOLD MEASUREMENTS WERE WITHIN NORMAL RANGE, HOWEVER HAVE INCREASED SLOWLY. A LEAD FRACTURE WAS SUSPECTED. NO NOISE WAS NOTED ON THE ELECTROGRAM WITH PROVOCATIVE STIMULATION. NO INAPPROPRIATE THERAPY HAD BEEN DELIVERED. NORMAL SENSING MEASUREMENTS WERE OBTAINED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AN X-RAY WILL BE PERFORMED AND A DECISION REGARDING LEAD REVISION WILL BE MADE IN THE FUTURE. SUBSEQUENTLY, A LEAD REVISION WAS PERFORMED. THE PACE/SENSE PORTION OF THIS LEAD WAS SURGICALLY ABANDONED AND AN ADDITIONAL PACE/SENSE LEAD WAS IMPLANTED. POST PROCEDURE, NORMAL MEASUREMENTS WERE OBTAINED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143973 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R F110| 0175