BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2811078 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16337
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 16, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 THE HELIX WAS DISTORTED/BENT. IT WAS NOTED THAT THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THE LEAD APPEARED DAMAGED AT IMPLANT. THE ANALYST COMMENTED THAT THE LEAD WAS RETURNED WITH THE HELIX DISTORTED/BENT. HOWEVER, THE HELIX WAS ABLE TO BE EXTENDED AND RETRACTED WITHIN SPECIFICATION. .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT OF THE RIGHT ATRIAL (RA) LEAD THERE WERE MULTIPLE EXTENSIONS AND RETRACTIONS OF THE HELIX DUE TO INADEQUATE SENSING AND THRESHOLDS. IT WAS THEN SEEN UNDER X-RAY THAT THE HELIX EXTENDED AT AN ANGLE FROM THE LEAD TIP. THE PHYSICIAN WAS CONCERNED ABOUT THE LEAD TISSUE CONTACT WITH THE BENT HELIX, SO THE RA LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. 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 55 YR Other