BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211259 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07758
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    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 APPROXIMATELY TWO MONTHS FOLLOWING THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. AN X-RAY REVEALED THAT THE SETSCREW MAY NEED TO BE TIGHTENED OR THE LEAD WAS NOT FULLY INSERTED. AFTER OPENING THE POCKET, IT WAS CONFIRMED THAT THE LEAD WAS SECURELY IN THE HEADER. THE LEAD WAS RE-INSERTED AND THE SETSCREW WAS SECURED. ALL MEASUREMENTS WERE APPROPRIATE FOLLOWING THE REVISION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310904 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R