BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 2790769 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14455
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    July 16, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 PATIENT EXPERIENCED DIZZINESS AND SHORTNESS OF BREATH DUE TO THE LEAD DISLODGING POST IMPLANT. IT WAS ALSO REPORTED THAT LEAD HAD INTERMITTENT NO CAPTURE AT HIGH OUTPUTS. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SENSE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4074

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR| 4076 IMPLANTABLE PACING LEAD