BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SENSE

    MDR report key: 1864811 · Received October 12, 2010

    Report

    Report Number
    2649622-2010-10925
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S034
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 THERE WAS HIGH THRESHOLD ON THE RIGHT VENTRICULAR LEAD. THE ASSOCIATED PACEMAKER WAS REPLACED TO ADDRESS THIS. THE LEAD 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 SENSE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4074 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention SESR01 IMPLANTABLE PULSE GENERATOR