BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2951509 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00117
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 19, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    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: THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND DURING ANALYSIS. BLOOD WAS NOTED ON THE DISTAL ELECTRODE AND PROXIMAL CONDUCTOR. THE HELIX WAS BENT AND OVERSTRESS DISTORTION WAS NOTED. THERE WAS A COSMETIC DEPRESSION IN THE OUTER INSULATION. THE INNER AND OUTER INSULATION WERE BREACHED CUT. THE PROXIMAL CONDUCTOR WAS KINKED/BUCKLED AND CUT. THE LEAD WAS STRETCHED AND EXPLANT DAMAGE WAS NOTED. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD 2012 (B)(6); 4296 IMPLANTABLE PACING LEAD 2012 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS REMOVED AND REPLACED DUE TO SHORT INTERVALS AND OVER SENSING. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56616 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR