BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2791545 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14843
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 17, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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). THE FULL LEAD WAS RETURNED AND ANALYZED. THE LEAD WAS STRETCHED. THE PROXIMAL CONDUCTOR WAS STRETCHED. THE HELIX/LOBE WAS DISTORTED/BENT AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THE TURNS TO EXTEND/RETRACT THE HELIX EXCEEDED SPECIFICATION. VISUAL ANALYSIS REVEALED THE LEAD WAS DAMAGED AT IMPLANT. THE HELIX WAS ABLE TO BE EXTENDED AND RETRACTED BUT ALL HELIX TESTS WERE OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THE HELIX DID NOT FULLY RETRACT AFTER THE SECOND ATTEMPT AT PLACING THE LEAD IN THE RIGHT ATRIAL APPENDAGE. THE LEAD WAS REMOVED FROM THE BODY, PHYSICALLY INSPECTED, AND THE HELIX WAS ABLE TO BE EXTENDED AND RETRACTED. ONCE THE LEAD WAS INTRODUCED BACK INTO THE BODY, IT WAS NOTED VIA FLUOROSCOPY THAT THE LEAD AGAIN WOULD NOT FULLY RETRACT. THE LEAD WAS NOT IMPLANTED AND ANOTHER LEAD WAS USED. 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 72 YR Other