BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1688709 · Received May 14, 2010

    Report

    Report Number
    2649622-2010-03982
    Event Type
    Malfunction
    Date Received
    May 14, 2010
    Date of Event
    October 30, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE IMPLANT PROCEDURE THAT THE RV LEAD WAS ATTEMPTED BUT NOT USED AS THE SUTURE SLEEVE "SNAGGED" THE LEAD'S INSULATION. THE ATRIAL LEAD WAS ALSO NOT IMPLANTED, WITH THE PHYSICIAN OPTING TO USE A PRE-FORMED ACTIVE J. NO 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 80 YR Required Intervention