BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2964426 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02071
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    October 26, 2012
    Report Date
    November 5, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES FOUND. IT WAS NOTED THAT THE HELIX WAS PULLED/STRETCHED/OVERSTRESSED. BLOOD WAS FOUND ON THE DISTAL END OF THE ELECTRODE. VISUAL ANALYSIS FOUND APPARENT EXPLANT DAMAGE. THE ANALYST COMMENTED THAT THE LEAD WAS RETURNED WITH THE HELIX STRETCHED/DISTORTED. THE STRETCHED/DISTORTED HELIX IS LIKELY DUE TO EXPLANT DAMAGE. DUE TO THE STRETCHED/DISTORTED HELIX, THE HELIX EXTENSION/RETRACTION/LENGTH TESTING COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REPORTED SHARP PAINS AND "BURNING" SENSATIONS AFTER IMPLANT OF THE PACING SYSTEM. ECHOCARDIOGRAM, X-RAYS AND ELECTROCARDIOGRAM DETERMINED THE RIGHT VENTRICULAR LEAD PERFORATED THE HEART. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66987 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407658

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R