BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2053269 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05828
    Event Type
    Injury
    Date Received
    April 13, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. 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. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS ALSO NOTED THAT THE OUTER INSULATION WAS BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM, AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTED LEAD HAD NO CAPTURE APPROXIMATELY TWO MONTHS AFTER IMPLANT. WHEN THE LEAD WAS EXPLANTED, IT WAS NOTICED THAT THE HELIX HAD A "STRANGE APPEARANCE." ANOTHER LEAD WAS SUCCESSFULLY 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. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R