BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2760967 · Received September 26, 2012

    Report

    Report Number
    2182208-2012-03152
    Event Type
    Injury
    Date Received
    September 26, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024/S2
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD AND THE LEFT VENTRICULAR LEAD BOTH HAD AN APPARENT FRACTURE. THE LEADS WERE ABANDONED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4968

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization| R 8042 IMPLANTABLE PULSE GENERATOR| 4968 IMPLANTABLE PACING LEAD