BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK C

    MDR report key: 3800005 · Received May 8, 2014

    Report

    Report Number
    2124215-2014-10371
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 20, 2014
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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 THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE (PLI) MEASUREMENT AND LOSS OF CAPTURE AT MAX OUTPUT. THE A LEAD FRACTURE WAS SUSPECTED. THE DEVICE AND THE 3 ADAPTERS WERE EXPLANTED WHILE THE RV LEAD WAS SURGICALLY ABANDONED. A NEW TRANSVENOUS SYSTEM WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279355 ENDOTAK C IMPLANTABLE LEAD LWS HISTORICAL CPI ST. PAUL 0074

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| L| R 6162| 6931| 0074| E161| MISMATCH