BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3212925 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10349
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 4, 2012
    Report Date
    June 20, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    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 NON-SUSTAINED VENTRICULAR TACHYCARDIA EVENTS RESULTED FROM OVERSENSING OF NOISE. ADDITIONALLY, A DROP IN PACING IMPEDANCE AND AMPLITUDE MEASUREMENTS WERE OBSERVED, ALONG WITH INCREASED THRESHOLD MEASUREMENTS. ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED AND DUE TO OVERSENSING AND INCREASED PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS, THIS RV LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311958 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R T177| 0158