BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2812016 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16156
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 19, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 FOR: (B)(4) - THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THE PHYSICIAN FELT THAT THE HELIX WOULD NOT FULLY RETRACT. THE HELIX WAS EXTENDED INTO THE TISSUE; THE PHYSICIAN WAS TRYING TO GET A GOOD POSITION. WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE HELIX, THE LEAD DISLODGED. A DIFFERENT LEAD WAS IMPLANTED. NO 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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other