BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 1991805 · Received February 15, 2011

    Report

    Report Number
    2182208-2011-00158
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 17, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S16
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    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 BY THE PATIENT THAT, SPORADICALLY FOR THE LAST 8 MONTHS, THEY FEEL "SKIPPED BEATS" AND WAS GETTING DIZZY. THE PATIENT ALSO REPORTED TO " HAVE A SQUEEZING IN MY CHEST". FURTHERMORE, THE PATIENT FEELS THERE IS SOMETHING WRONG WITH THE LEAD, AND INQUIRED ABOUT IT. THE LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE PATIENT STATES "EVERY ONCE IN A WHILE I FEEL A TIGHT SQUEEZE THEN TINGLING IN MY FINGERS. IT'S SPORADIC, THEN SOMETIMES IT WILL HAPPEN FIVE DAYS IN A ROW, NOW THE TINGLING IS FELT IN MY HEAD." THE PATIENT IS WONDERING IF THIS IS RELATED TO HIS DEVICE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT, SPORADICALLY FOR THE LAST 8 MONTHS, THEY FELL "SKIPPED BEATS" AND WAS GETTING DIZZY. THE PATIENT ALSO REPORTED TO "HAVE A SQUEEZING IN MY CHEST". FURTHERMORE, THE PATIENT FEELS THERE IS SOMETHING WRONG WITH THE LEAD, AND INQUIRED ABOUT IT. THE LEAD REMAINS IN USE. NO FURTHER 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, INC. 5524M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other 4194 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| C154DWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB