BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SENSE

    MDR report key: 3160266 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07969
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY - THE FULL LEAD WAS RETURNED AND ANALYZED. THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS OBSTRUCTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN WAS UNABLE TO INTRODUCE THE STYLET INTO THE IMPLANTABLE PACING LEAD. THE PHYSICIAN ALLEGES THAT THE LEAD IS DEFECTIVE. THE LEAD WAS NOT USED ON THE PATIENT. THE DIFFICULTY OCCURRED OVER THE STERILE FIELD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260666 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407458

    Patients

    Seq Age Sex Outcome Treatment
    1