BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1926189 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14218
    Event Type
    Injury
    Date Received
    December 14, 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
    MN, 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 AND ANALYZED. PRIMARY ANALYSIS SHOWED NO ANOMALIES. ADDITIONALLY THE PROXIMAL CONDUCTOR WAS DISTORTED, THE OUTER INSULATION WAS BREACHED/CUT, THE OUTER INSULATION HAD COSMETIC DEPRESSION, AND THERE WAS APPARENT EXPLANT DAMAGE. BLOOD AND BODY FLUID WERE PRESENT ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED) AND HELIX. THERE WAS A LARGE AMOUNT OF TISSUE ON THE HELIX.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD RISING THRESHOLDS AND SENSING DEPRECIATION. THE LEAD WAS EXPLANTED AND REPLACED. 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 77 YR Hospitalization| R P1501DR IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD