BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIXNOVUS

    MDR report key: 3051785 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04901
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 8, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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: ADDRL1 IMPLANTABLE PULSE GENERATOR (IPG) (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INITIAL IMPLANT PROCEDURE THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS WERE INSERTED INTO THE INCORRECT PORT OF DEVICE HEADER. A REVISION PROCEDURE WAS CONDUCTED TO REPOSITION THE LEADS INTO THE CORRECT LEAD PORT AND BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152645 CAPSUREFIXNOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Hospitalization| R 5092 IMPLANTABLE PACING LEAD