BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2203181 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11836
    Event Type
    Injury
    Date Received
    August 11, 2011
    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
    TX, 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, ANALYZED AND THE DISTAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THE HELIX WAS DISTORTED/BENT AND THERE WAS BLOOD IN/ON THE HELIX MECHANISM. (B)(4): THE DISTAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND THE INNER INSULATION WAS BREACHED - METAL INDUCED OXIDATION. IT WAS NOTED THAT THE INNER AND OUTER INSULATION HAD COSMETIC METAL INDUCED OXIDATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD HAD HIGH IMPEDANCE AND OVERSENSING. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD LOW IMPEDANCE. BOTH LEADS WERE 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 74 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR