BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE EPI

    MDR report key: 2051318 · Received April 12, 2011

    Report

    Report Number
    2182208-2011-00522
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 27, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024/S2
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, 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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED, AND PRIMARY ANALYSIS REVEALED NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD HIGH IMPEDANCE WHEN A NEW DEVICE WS IMPLANTED. THE LEAD REMAINS IN USE. THE IMPLANTER FELT THE DEVICE WAS "DEFECTIVE" AT IMPLANT BECAUSE OF THE HIGH ATRIAL LEAD IMPEDANCE MEASUREMENT. THE DEVICE WAS NOT IMPLANTED AND REPLACED. 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 EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4968 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other 4968 IMPLANTABLE PACING LEAD