BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1791796 · Received August 10, 2010

    Report

    Report Number
    2649622-2010-06952
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    January 23, 2009
    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
    LU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. 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. WITHOUT THE DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS UNDERSENSING, DISLODGEMENT, AND A PERFORATION AFTER IMPLANT OF THE VENTRICULAR LEAD. THE LEAD WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS ADDITIONALLY REPORTED THAT THE ATRIAL LEAD DISLODGED TWO DAYS AFTER IMPLANT. THE LEAD WAS REPLACED. 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. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention