BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3864731 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07543
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    December 1, 2013
    Report Date
    April 21, 2014
    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
    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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: SDR303B IPG, IMPLANTED: (B)(6) 2002. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DEVICE WAS REPROGRAMMED AND A DEVICE AND ATRIAL LEAD REPLACEMENT IS PLANNED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED A BURNING AROUND THE DEVICE AND A SHOCK DOWN THE SIDE THAT OCCURRED SEVERAL MONTHS AGO. THE PATIENT WAS SEEN AND ADJUSTMENTS WERE MADE. THE FEELING WENT AWAY BUT LAST WEEK THEY BEGAN AGAIN. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEEN A SECOND TIME AND THE ATRIAL LEAD SHOWED VARIABLE AND HIGH IMPEDANCE AND OVERSENSING WITH POCKET MANIPULATION. IT WAS NOTED THAT THE BURNING SENSATION MAY BE DUE TO THE ATRIAL LEAD OR DUE TO A POTENTIAL WIRE BOND LIFT WITH THE DEVICE. THE DEVICE AND ATRIAL LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338401 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4568-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Required Intervention 5092-58 LEAD