BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2203694 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11723
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 19, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 AND NO ANOMALIES WERE FOUND. BLOOD WAS FOUND IN/ON THE HELIX LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT ATTEMPT OF THE RIGHT VENTRICULAR LEAD THE LEAD SHOWED HIGH IMPEDANCES AND WAS REPOSITIONED MULTIPLE TIMES WITHOUT SUCCESS DUE TO A SCARRING ISSUE IN THE HEART. THE LEAD WAS NOT IMPLANTED. ADDITIONALLY, IT WAS REPORTED THAT THE NEW RIGHT VENTRICULAR LEAD HAD INCREASED IMPEDANCES AND HAD TO BE REPOSITIONED MULTIPLE TIMES UNTIL THE LEAD WAS SUCCESSFULLY IMPLANTED. 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 84 YR Other