BEUDAMED
    FDA Adverse Event Summary report: N

    NBIH BIPOLAR PACING ELECTRODE CATHETER

    MDR report key: 1981758 · Received December 13, 2010

    Report

    Report Number
    1222791-2010-00006
    Date Received
    December 13, 2010
    Date of Event
    September 30, 2010
    Report Date
    November 18, 2010
    Manufacturer
    C.R. BARD INC. (BEP)
    Product Code
    LDF
    PMA / PMN Number
    PMA
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE DOCTOR ON (B)(6) 2010, INDICATED THAT DURING USE OF THIS DEVICE IN (B)(6) 2010, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NBIH BIPOLAR PACING ELECTRODE CATHETER LDF C.R. BARD INC. (BEP) GFTJ0930

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other