BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 2955404 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01397
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    December 11, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 CONTINUED: 4092-52 IMPLANTABLE PACING LEAD (B)(6) 2013; (B)(4) IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, A FEW YEARS AGO, THE ATRIAL LEAD TRIGGERED AN ALERT FOR LOW IMPEDANCE. THE LEAD ALSO SHOWED LOW IMPEDANCE AT THE IMPLANT OF THE NEW DEVICE. THE 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
    58626 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4568-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)