BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3223528 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-10751
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 6, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. IT WAS ALSO REPORTED THAT NOISE WAS NOTED ON PRESENTING ELECTROGRAM (EGM) BUT THERE WAS NO OVERSENSING . BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLE-SHOOTING AND TRYING DIFFERENT CONFIGURATIONS. TS FURTHER SUGGESTED DOING A COMMANDED SHOCK TEST TO HAVE THE MOST ACCURATE REPRESENTATION OF TRUE IMPEDANCE. ADDITIONAL INFORMATION WAS RECEIVED THAT IT WAS NOTED ON FLUOROSCOPY THAT THERE MAY HAVE BEEN AN ABNORMAL BEND IN THE PROXIMAL PORTION OF THE LEAD. THE SOURCE OF NOISE WAS NOT DETERMINED. THIS PATIENT UNDERWENT A REVISION PROCEDURE AND THIS LEAD WAS SURGICALLY CAPPED AND ABANDONED. THE RV LEAD IS NO LONGER IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323316 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R N161| 0185| 4543| 4087| E102