BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SENSE

    MDR report key: 3153074 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05803
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE PROXIMAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING AND THE DISTAL CONDUCTOR WAS EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING. THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS OBSTRUCTED. THE DISTAL LV (LEFT VENTRICULAR) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. ANALYST COMMENTED ELECTRICAL RESISTANCE RESULT WAS WITHIN SPECIFICATION. MICROSCOPIC ANALYSIS INSPECTION FOUND ONLY CONDUCTORS DISTORTED/EXTRINSIC. NO FRACTURED WAS OBSERVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTRODE WAS BROKEN. THE LEAD WAS ATTEMPTED AND NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255994 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407358

    Patients

    Seq Age Sex Outcome Treatment
    1 Other