BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 2952768 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00229
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 12, 2006
    Report Date
    December 13, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO EVAL EXPLANATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD DISLODGED. THE LEAD WAS REPOSITIONED AND REMAINED IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57456 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC 4074

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R P1501DR IMPLANTABLE PACEMAKER