BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3860942 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06822
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 13, 2014
    Report Date
    April 13, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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: VEDR01 IPG (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DAY AFTER LEAD PLACEMENT, THE PHYSICIAN THOUGHT THE ATRIAL LEAD DISLODGED BASED ON A CHEST X-RAY. AN INTERROGATION AND FLUOROSCOPY IMAGING SHOWED THAT THE LEAD WAS STILL ATTACHED AND WORKING FINE BUT THE TYPICAL J SHAPED LEAD SLACK HAD MOVED INTO SVC AND THE LEAD WAS POINTING DOWNWARD. THE DECISION WAS MADE TO ADD SLACK BACK INTO THE LEAD WITHOUT REPOSITIONING. THAT WAS DONE WITHOUT INCIDENCE AND THE LEAD REMAINS 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
    343071 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R 5076-52 LEAD