BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3990695 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08539
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 PRODUCT: 6935M62 LEAD IMPLANTED (B)(6) 2014; 419488 LEAD IMPLANTED (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD POST-OPERATIVELY DISLODGED AND HAD TO BE REPOSITIONED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXPERIENCING PHRENIC NERVE AND CHEST WALL STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. REPROGRAMMING WAS ABLE TO RESOLVE THE STIMULATION BUT THE PHYSICIAN STILL OPTED TO REPOSITION THE LV LEAD AT THE TIME OF RA LEAD REVISION. 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
    471967 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R DTBA1D4 ICD