BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSFIX PU SCR.-IN

    MDR report key: 2964859 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01916
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    December 11, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 PRODUCT: 4092 IMPLANTABLE PACING LEAD (B)(6) 2001. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD HAD LOW IMPEDANCE AND A LEAD WARNING WAS TRIGGERED. IT WAS ALSO NOTED THAT THE BIPOLAR IMPEDANCE WAS LESS THAN THE UNIPOLAR IMPEDANCE AND A POLARITY SWITCH OCCURRED. THE LEAD WAS REPROGRAMMED AND 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
    67268 CAPSFIX PU SCR.-IN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4568-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Required Intervention ADDR01 IMPLANTABLE PACEMAKER