BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2781073 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12941
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 20, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 ONE DAY POST IMPLANT OF THIS RIGHT VENTRICULAR (RV) LEAD, R-WAVE MEASUREMENTS HAD DECREASED TO 0.9MV, WITH PACING IMPEDANCE MEASUREMENTS AT 232 OHMS, SHOCK IMPEDANCE MEASUREMENTS AT 52 OHMS AND NO CAPTURE AT MAXIMUM OUTPUTS. A CHEST XRAY CONFIRMED THAT THE RV LEAD HAD DISLODGED. THE PATIENT EXHIBITED NO SYMPTOMS AS A RESULT. A REVISION PROCEDURE WAS PERFORMED AND THE RV LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R 6942| E140| 0293| T135| MISMATCH