BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3152431 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06817
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE INNER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A TEAR. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING, THE DISTAL CONDUCTOR WAS EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING, THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A TEAR, THE INNER INSULATION OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS, THE OUTER INSULATION OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS, VISUAL ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT, AND VISUAL ANALYSIS OF THE LEAD INDICATED STRETCHING. CROSS CONTINUITY TEST RESULT FAILED DUE TO THE INNER INSULATION BEING EXTRINSICALLY BREACHED DUE TO A TEAR. PRODUCT ID REDR01 IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS BIPOLAR STIMULATION LOSS AND THERE WAS A REVISION. DURING A FOLLOWUP SESSION IT WAS NOTED THAT THERE WAS A WARNING FOR LOW RIGHT VENTRICULAR (RV) LEAD IMPEDANCE. THE PATIENT REPORTED INTERMITTENT DIZZINESS, AND DURING INTERROGATION THE PATIENT BECAME PRESYNCOPAL AND NO PACING WAS OBSERVED. AFTER REPROGRAMMING TO UNIPOLAR THERE WAS NORMAL RV STIMULATION, AND INTERROGATION OF THE DEVICE SHOWED NORMAL IMPEDANCE VALUES. EXIT BLOCK WAS NOTED WITH VENTRICULAR PACING. IT WAS DECIDED TO EXPLANT AND REPLACE BOTH THE RV LEAD AND THE DEVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252726 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5092-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R