BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2811053 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15827
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    July 20, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S15
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 A PREVIOUSLY CAPPED LEAD WAS UNCAPPED AND USED AS A PACE\SENSE LEAD. IT WAS ALSO REPORTED THAT A "SUBTLE NOISE" WAS SEEN FROM THE WIRELESS TRANSMISSION FEW WEEKS AFTER THE LEAD WAS USED. THE PATIENT WAS BROUGHT INTO THE OFFICE AND THE "SUBTLE NOISE" WAS OBSERVED WHEN THE PATIENT WAS DOING PUSH UP LIKE MOTION. THE LEAD WAS CAPPED AND THE PACE\SENSE PORTION WAS HOOKED BACK ONTO THE CURRENT HIGH VOLTAGE RIGHT VENTRICULAR LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5024M

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB