BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3153654 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06148
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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. (B)(4) IMPLANTABLE PULSE GENERATOR (IPG) 2006 (B)(6); 5068 IMPLANTABLE PACING LEAD 1999 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOWUP INFORMATION FROM THE CLINIC INDICATES THE ATRIAL LEAD WAS OVERSENSING AND REPROGRAMMING WAS DONE TO SUPPRESS ATRIAL PACING. IT WAS FURTHER REPORTED BY THE PATIENT THAT THEY ARE EXPERIENCING PACEMAKER-MEDIATED TACHYCARDIA AND THE PATIENT REQUESTED TO HAVE THE PACEMAKER TURNED OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT A YEAR AND A HALF AGO THE ATRIAL LEAD HAD LOW IMPEDANCE AND A POLARITY SWITCH OCCURRED. THE LEAD WAS TURNED OFF AT THAT TIME, HOWEVER RECENTLY THE LEAD WAS CHECKED AND THE IMPEDANCES WERE FINE SO THE LEAD WAS TURNED BACK ON. THE PATIENT ALSO STATES THEY HAVE SYMPTOMS OF SWEATING, GRAY COLOR, AND SEVERE PVCS, AND THAT THEY FEEL LIKE BEFORE THEY HAD THEIR PACEMAKER. 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
    256450 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5068-45

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention