BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3051213 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04830
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    October 29, 2012
    Report Date
    November 28, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
    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

    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. CONCOMITANT PRODUCT: 4076, IMPLANTABLE PACING LEAD, (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE LEAD SEGMENTS WAS RETURNED TO THE MANUFACTURER AND ANALYZED. A CUT WAS OBSERVED ON THE OUTER INSULATION. THE LEAD CONDUCTOR PROXIMAL END WAS DISTORTED PULLED/STRETCHED/OVERSTRESS; FRACTURED AND THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR NOT OBSTRUCTED. THE DISTAL END ELECTRODE WAS COVERED IN BLOOD. OUTER INSULATION ON THE LEAD WAS BREACHED MELTED AND TORN. THE LEAD HAD APPARENT DAMAGE AT IMPLANT AND WAS STRETCHED. DUE TO THE LARGE AMOUNT OF BLOOD ON THE PROXIMAL CONDUCTOR, IT IS LIKELY THAT THE CUT OCCURRED DURING THE IMPLANT. THE RESULTING INGRESS OF BLOOD WOULD CONTRIBUTE TO THE RISING LEAD THRESHOLD. THE RETURNED LEAD ALSO HAD SEVERE EXPLANT DAMAGE INCLUDING A STRESS FRACTURE ON THE PROXIMAL CONDUCTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD THRESHOLD ROSE ACUTELY POST IMPLANT. THEREFORE THE RV LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153180 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA 407658

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ADDRL1 IMPLANTABLE PACEMAKER