BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR IS-1 ATRIAL J RA 45, 52, 59 CM

    MDR report key: 1684935 · Received May 7, 2010

    Report

    Report Number
    2124215-2010-06383
    Event Type
    Injury
    Date Received
    May 7, 2010
    Date of Event
    March 12, 2010
    Report Date
    May 7, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR IS-1 ATRIAL J RA 45, 52, 59 CM IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4271 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR