BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2955248 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01010
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    July 2, 2012
    Report Date
    November 20, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN A FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT COULD NOT BE DETERMINED IF THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (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

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

    Description of Event or Problem · 1

    IT WAS ADDITIONALLY REPORTED THAT THE RIGHT ATRIAL (RA) LEAD SWITCHED TO UNIPOLAR AGAIN. TESTING FOUND LOW IMPEDANCE, NO CAPTURE, AND NO SENSING OF P-WAVES. THE LEAD WAS REPROGRAMMED BACK TO BIPOLAR. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POLARITY SWITCH OCCURRED ON THE RIGHT ATRIAL (RA) LEAD. LOW IMPEDANCE WAS NOTED. THE LEAD WAS REPROGRAMMEDBACK TO BIPOLAR CONFIGURATION AND REMAINS IN USE. NO PATIENT WAS INVOLVED. NO COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59258 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4568-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention (B)(4) IMPLANTABLE PULSE GENERATOR