BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2170768 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-11027
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    August 26, 2010
    Report Date
    June 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THERE HAS BEEN NO RETURN OF PRODUCT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE REPLACEMENT PROCEDURE THIS RIGHT VENTRICULAR (RV) LEAD WAS REMOVED AND REPLACED. THE REASON FOR THIS REVISION IS UNKNOWN AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention (B)(4)| MISMATCH| (B)(4)| (B)(4)| (B)(4)| (B)(4)