BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1991757 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02536
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 28, 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 Location
    OH, 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 IN SEGMENTS AND ANALYSIS REVEALED NO ANOMALIES. IT WAS NOTED THAT THE INNER INSULATION WAS KINKED/BUCKLED, THERE WAS A COSMETIC DEPRESSION ON THE OUTER INSULATION AND THERE WAS APPARENT EXPLANT DAMAGE. BLOOD/BODY FLUID WAS ALSO NOTED ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED) AND ON THE HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE DEVICE CHANGEOUT, THE ATRIAL LEAD WAS SACRIFICED TO TRY TO MAKE MORE ROOM FOR THE LEFT VENTRICULAR (LV) LEAD DUE TO AN OCCLUSION. A NEW ATRIAL LEAD WAS PLACED. 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. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R 7274 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD