BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 1861673 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-10113
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    April 30, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S12
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 VENTRICULAR LEAD IMPEDANCE WAS LOW, THRESHOLD HAD RISEN SINCE THE LAST INTERROGATION, AND THAT THERE WAS A CONCERN THAT THESE MEASUREMENTS WOULD BE AFFECTED BY THE ELECTIVE REPLACEMENT INDICATOR THAT OCCURRED LATE (B)(6) 2010. THE DEVICE REMAINS 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
    1 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4024 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other 7088B IMPLANTABLE PULSE GENERATOR| 4568 IMPLANTABLE PACING LEAD