BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2130224 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10134
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND PRIMARY ANALYSIS REVEALED THAT THE OUTER INSULATION WAS BREACHED CUT. BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED) AND IN/ON THE HELIX MECHANISM. THE OUTER INSULATION HAD COSMETIC METAL ION OXIDATION (MIO), COSMETIC ENVIRONMENTAL STRESS CRACKING (ESC) AND COSMETIC DEPRESSION. THERE WAS ALSO APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD OVERSENSING NOISE APPEARING IN BOTH BIPOLAR AND UNIPOLAR CONFIGURATIONS. IT WAS ALSO NOTED THAT THE SUTURE WAS ON THE LEAD AND HAD DAMAGED THE OUTER INSULATION. THE LEAD WAS REMOVED 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. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR| 5568 IMPLANTABLE PACING LEAD