BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 1990622 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02098
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 10, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 THE OUTER INSULATION WAS PERFORATED BY THE STYLET/GUIDEWIRE. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT AND THE LEAD APPEARED DAMAGED AT IMPLANT. EVALUATION SUMMARY: (B)(4) OUTER INSULATION PERFORATED (STYLET/GUIDEWIRE). (B)(4) FULL LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT ATTEMPT THE STYLET PERFORATED THE LEAD NEAR THE LEAD CONNECTOR PIN. THE LEAD WAS NOT IMPLANTED AND A DIFFERENT 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 CAPSURE Z NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5554 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other