BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1922959 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13152
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 ATRIAL UNDERSENSING DURING A HIGH RATE EPISODE. IT WAS NOTED TO HAVE OCCURRED IN BOTH THE VENTRICULAR PACE AND SENSE INTERVALS. VENTRICULAR PACING OUTPUTS WERE HIGH. MODE SWITCH WAS PROGRAMMED ON. THE LEADS ARE STILL 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 NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR