BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 3152889 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05723
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 9, 2013
    Report Date
    March 9, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. PRODUCT ID 457445 IMPLANTABLE PACING LEAD, (B)(6) 2013. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THAT THE OUTER INSULATION OF THE LEAD WAS EXTRINS ICALLY BREACHED DUE TO A CUT. THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED. THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY CUT BUT NOT BREACHED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    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 DAY AFTER IMPLANT THERE WAS AN INCREASE IN THRESHOLD ON THE VENTRICULAR LEAD. AN X-RAY CONFIRMED A CARDIAC PERFORATION. THE LEAD WAS SUBSEQUENTLY 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
    257851 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407458

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| L| R A3DR01 IMPLANTABLE PULSE GENERATOR (IPG)