BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3861582 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07223
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    April 9, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. CONCOMITANT PRODUCTS: 4471, COMPETITOR LEAD, IMPLANT DATE: (B)(6) 2008; 4194, LEAD, IMPLANT DATE: (B)(6) 2004; D334TRG, ICD, IMPLANT DATE: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH SYNCOPE. THE LEAD WAS DESCRIBED AS "BROKEN" AND "FAILED". DUE TO NOISE ON THE PACE/SENSE PORTION OF THE LEAD, IT WAS DETERMINED TO BE FRACTURED. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED. THE INSULATION ON THE HIGH VOLTAGE PORTION OF THE LEAD WAS REPAIRED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR LEAD PACE/SENSE PORTION FAILED APPROXIMATELY 6 YEARS AGO. THE PACE/SENSE PORTION OF THE LEAD WAS REPLACED. IT WAS LATER REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD HIGH IMPEDANCE AND A POSSIBLE FRACTURE. THE LEAD WAS EXPLANTED AND REPLACED. WHILE EXTRACTING THE LEAD, THE ATRIAL LEAD HAD DISLODGED. THE ATRIAL LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343190 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R 6949 LEAD