BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1992166 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-03001
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    July 21, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND THE OUTER INSULATION HAD A BREACHED DEPRESSION. IT WAS ALSO NOTED THAT THE OUTER INSULATION WAS KINKED/BUCKLED, ALL INSULATORS WERE BREACHED CUT AND THERE WAS A COSMETIC DEPRESSION ON THE OUTER INSULATION. BLOOD/BODY FLUID WAS ALSO NOTED ON ALL CONDUCTORS (NOT OBSTRUCTED) AND ON THE HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE RIGHT VENTRICULAR PACING LEAD HAD TO BE EXTRACTED TO REPLACE ANOTHER LEAD. THE LEAD WAS REPLACED. 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 53 YR Hospitalization| R 6931 IMPLANTABLE TACHY LEAD| 7298 IMPLANTABLE PACEMAKER/CARDIO/DEFIB