BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3861498 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07251
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 MEDICAL PRODUCTS: 4074 LEAD, (B)(6) 2004; VEDR01 IPG, (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. THE DISTAL CONDUCTOR OF THE LEAD WAS EXTRINSICALLY OVER-ROTATED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD LOW IMPEDANCE, NO SENSING, AND NO CAPTURE. DURING THE REPLACEMENT PROCEDURE, THE ATTEMPTED LEAD WAS PLACED AND THEN DISLODGED. THE PHYSICIAN WAS THEN UNABLE TO EXTRACT THE SCREW AND UNABLE TO GET THE STYLET INTO THE LEAD. NO NEW ATRIAL LEAD WAS IMPLANTED AND THE ORIGINAL LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342673 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5568-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| R 4568-45 LEAD