BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3864818 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07498
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 5, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND THE INNER INSULATION OF THE LEAD WAS EX TRINSICALLY BREACHED DUE TO A TEAR. THE PROXIMAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING. THE DISTAL CONDUCTOR WAS EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING. THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 4092-58 LEAD, IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DISLODGED AND WAS FOUND SENSING OF THE ATRIUM AND VENTRICLE. THE LEAD ALSO HAD NO CAPTURE. A REPOSITION ATTEMPT WAS MADE, BUT THE LEAD WAS DAMAGED DURING EXCISION FROM THE POCKET. THE RA LEAD WAS EXPLANTED AND WAS REPLACED WITH A NEW LEAD. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS ALSO DAMAGED DURING EXCISION FROM THE POCKET IN AN ATTEMPT TO REPOSITION THE ATRIAL LEAD. THE RV LEAD WAS ALSO EXPLANTED AND WAS 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
    338522 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 457445

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R VEDR01 IPG