BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE EPI

    MDR report key: 1862826 · Received October 9, 2010

    Report

    Report Number
    2182208-2010-00764
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    June 18, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024/S2
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD A FRACTURE AND HIGH IMPEDENCE. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 Required Intervention 4968 IMPLANTABLE PACING LEAD| KDR933 IMPLANTABLE PULSE GENERATOR