BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1926467 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14337
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 8, 2010
    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
    AU
    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 IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC CUT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD IN/ON THE HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL SENSING AMPLITUDE HAD DECLINED AND REPOSITIONING WAS NOT SUCCESSFUL. THE LEAD WAS REMOVED. ANOTHER LEAD WAS USED AND THIS LEAD DID NOT REMAIN IN POSITION AS WELL. A THIRD 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