BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1863122 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-10439
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    July 19, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. POXIMAL CONDUCTOR HAD BLOOD/BODY FLUID AND BLOOD ON HELIX/LOBE MECHANISM. FULL LEAD RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND. PROXIMAL CONDUCTOR BLOOD. FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT TESTED POSITIVE FOR A SILICONE ALLERGY. THE DEVICE AND LEADS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE 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. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention