BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1921390 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12500
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 4, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 THE PATIENT'S NEWLY IMPLANTED ATRIAL LEAD HAD INTERMITTENT UNDERSENSING AND POSSIBLE LOSS OF ATRIAL CAPTURE. THE LEAD IS STILL IN USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4592 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR