BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SENSE

    MDR report key: 1923021 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13185
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    THE PATIENT REPORTED THAT THEY HAVE NOT HAD A DEVICE CHECK FOR AT LEAST ONE YEAR BUT AT THE LAST CHECK THEY STATED THEY WERE TOLD BY THE PHYSICIAN THAT THE PACEMAKER WAS NOT WORKING AND ONE OF THE LEADS IS LEAKING. THE PATIENT STATED THEY WERE PUT ON MEDICATION. SINCE THAT TIME THEY INDICATED THAT THE HAVE FELT CHEST PRESSURE, FATIGUE AND HAVE BEEN USING NITRO "OFTEN". THEY HAVE NOT SEEN THEIR PHYSICIAN. THE LEADS AND DEVICE REMAIN IN USE. NO FURTHER 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. 4574 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other