BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 6195208 · Received December 21, 2016

    Report

    Report Number
    2124215-2016-20239
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    November 16, 2016
    Report Date
    December 5, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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 HIGH OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS, OVERSENSED NOISE AND LOSS OF CAPTURE (LOC) INDICATIVE OF LEAD FRACTURE. THE FRACTURE COULD NOT BE VISUALLY CONFIRMED BUT PACING SYSTEM ANALYZER (PSA) MEASUREMENTS CONFIRMED OUT-OF-RANGE IMPEDANCE MEASUREMENTS. SURGICAL INTERVENTION WAS PERFORMED BUT THE PHYSICIAN WAS UNABLE TO SUCCESSFULLY IMPLANT A REPLACEMENT LEAD AS SUCH THIS LEAD REMAINS IMPLANTED. ADDITIONAL INTERVENTION IS PLANNED TO IMPLANT A NEW SYSTEM ON THE RIGHT SIDE OF THE PATIENT'S CHEST. THE PATIENT IS NOT PACEMAKER DEPENDENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED INDICATES THAT THIS LEAD WAS LATER CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845138 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0148