BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1718717 · Received June 11, 2010

    Report

    Report Number
    2182208-2010-00334
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S27
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 PHYSICIAN HAS BEEN NOTICING HIGHER IMPEDANCE VALUES AT IMPLANT FOR THIS TYPE OF LEAD. PHYSICIAN HAD PREVIOUSLY MEASURED IMPEDANCES IN THE 400-450 OHMS RANGE. THE PHYSICIAN IS NOW SEEING IMPEDANCES IN THE 900-970 OHMS RANGE AT IMPLANT. NO PATIENT COMPLICATIONS WERE 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, INC. 4092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other