BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3992321 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09944
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    February 26, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. CONTINUATION OF CONCOMITANT PRODUCT: ADDR01 IPG, (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A POSSIBLE POCKET INFECTION. THE PATIENT REPORTED THAT THE SWOLLEN AREA OF THEIR POCKET HAD DOUBLED OVER THE PAST COUPLE HOURS AND HAD BEEN PROBLEMATIC FOR TWO WEEKS. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED. DURING THE REPLACEMENT PROCEDURE IT WAS NOTED THAT THE VENTRICULAR LEAD HAD EVIDENCE OF A SMALL INSULATION DEFECT. THE LEAD WAS REPAIRED USING MEDICAL GRADE SILICONE AND REMAINS IN USE. IT WAS ALSO NOTED THAT THE NON-FUNCTIONAL ATRIAL LEAD WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467124 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00089 YR Hospitalization| R 5076-58 LEAD