BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NBIH BIPOLAR PACING ELECTRODE CATHETER

    MDR report key: 1931220 · Received December 13, 2010

    Report

    Report Number
    1222791-2010-00007
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    June 30, 2010
    Report Date
    November 18, 2010
    Manufacturer
    C.R. BARD, INC. (BEP)
    Product Code
    LDF
    Adverse Event
    Yes
    Product Problem
    Yes
    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

    INFO RECEIVED (B)(6) 2010 FOLLOWING A VISIT TO THE PHYSICIAN INDICATES THAT DURING USE OF THIS DEVICE IN (B)(6) 2010, THE PT DEVELOPED A PERICARDIAL EFFUSION. THERE WAS NO REQUIRED MEDICAL OR SURGICAL INTERVENTION.

    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 62 YR Other