BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE

    MDR report key: 142795 · Received July 10, 1997

    Report

    Report Number
    2649622-1997-00457
    Event Type
    Injury
    Date Received
    July 10, 1997
    Date of Event
    April 4, 1997
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ALLEGED MALFUNCTION, EPISODE OF V-FIB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE Implant IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4003 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other 8427 IMPLANTABLE PULSE GENERATOR