BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3213698 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09984
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 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 THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE AND OVERSENSING BELIEVED TO BE DUE TO FRACTURE. ADDITIONAL INFORMATION CONFIRMED NOISE AND OVERSENSING ON RV LEAD. THIS RV LEAD WAS REPLACED AND WILL NOT BE RETURNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312375 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R N141| N164| 0158| 4518| 0185| T180| H179| 4088