BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4830741 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05914
    Event Type
    Injury
    Date Received
    June 10, 2015
    Report Date
    April 1, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD POCKET PAIN ONCE AGAIN AND HAD ANOTHER POCKET REVISION. THE DEVICE WAS REPOSITIONED. DURING THE REVISION PROCEDURE, THE PHYSICIAN NOTED THAT THE ATRIAL LEAD HAD AN EXTERNAL INSULATION BREAK. TESTING OF THE LEAD SHOWED ELEVATED IMPEDANCE. THE LEAD WAS REPAIRED WITH SURGICAL ADHESIVE AND A SLEEVE. THE LEAD REMAINS IN USE. THE PATIENT IS ENROLLED IN THE PRODUCT SURVEILLANCE REGISTRY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380508 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407645

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR Hospitalization| R (B)(4) IPG, (B)(4) LEAD