BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1863246 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-11400
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    August 11, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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) NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND. THE FULL LEAD WAS RETURNED AND ANALYZED. PROXIMAL CONDUCTOR HAD BLOOD, OUTER INSULATION BREACHED CUT, BLOOD ON HELIX. (B)(4) NO ANOMALIES FOUND. THE FULL LEAD WAS RETURNED AND ANALYZED. PROXIMAL CONDUCTOR HAD BLOOD, OUTER INSULATION BREACHED CUT, BLOOD ON HELIX.

    Description of Event or Problem · 1

    SEPSIS REPORTED. THE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention