BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1920712 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12328
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    July 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) PRELIMINARY ANALYSIS REVEALED AN ISSUE WITH THE CONNECTOR; THE FULL LEAD WAS RETURNED FOR ANALYSIS. FURTHER TESTING REVEALED PROXIMAL CONDUCTOR WAS DISTORTED, BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED) AND ON THE HELIX SLEEVE HEAD AND MECHANISM, THE OUTER INSULATION WAS BREACHED CUT, AND THE LEAD WAS STRETCHED. (B)(4): PRELIMINARY ANALYSIS REVEALED AN ISSUE WITH THE CONNECTOR; THE FULL LEAD WAS RETURNED FOR ANALYSIS. FURTHER TESTING REVEALED BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED) AND ON THE HELIX SLEEVE HEAD AND MECHANISM, AND THE OUTER INSULATION WAS BREACHED CUT. IT WAS NOTED THAT THE LEAD WAS RETURNED WITH THE GUIDE TOOTH DAMAGED.

    Description of Event or Problem · 1

    BOTH LEADS WERE REMOVED DUE TO INFECTION, RETURNED TO THE MANUFACTURER, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. 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 68 YR Required Intervention ADDRL1 IMPLANTABLE PULSE GENERATOR