BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3992039 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10088
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 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
    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. THE INITIAL REPORTED EVENT WAS RECEIVED ON (B)(4) 2014. OF NOTE, THE REPORTABLE MALFUNCTION AND/OR SERIOUS INJURY (INFECTION) IS NORMALLY SUBMITTED VIA AN ALTERNATIVE SUMMARY REPORT SUBMISSION THAT WOULD HAVE BEEN SUBMITTED ON (B)(6) 2014. INFORMATION WAS SUBSEQUENTLY RECEIVED ON (B)(4) 2014 AND REVEALED THE LEAD TESTED OUT OF SPECIFICATION. THIS EVENT NO LONGER QUALIFIES FOR SUMMARY REPORTING AND IS THEREFORE BEING SUBMITTED AS A BIMONTHLY REPORT. PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO A DEPRESSION WHILE IN VIVO. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION. THE LEAD WAS REMOVED. THE RIGHT ATRIAL LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468976 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Hospitalization| R ADDRL1 IPG, 5076-52 LEAD