BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELUTE PICOTIP AJ (PHASE II) BIPOLAR IS-1 ATRIAL J STEROID R

    MDR report key: 1704381 · Received May 21, 2010

    Report

    Report Number
    2124215-2010-08821
    Event Type
    Injury
    Date Received
    May 21, 2010
    Date of Event
    April 1, 2010
    Report Date
    May 21, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELUTE PICOTIP AJ (PHASE II) BIPOLAR IS-1 ATRIAL J STEROID R IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4063 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other