BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3153544 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06073
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 5076 IMPLANTABLE PACING LEAD (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PLEURAL EFFUSION AND A POSSIBLE PERFORATION OR DISLODGEMENT POST IMPLANT. RIGHT VENTRICULAR (RV) LEAD IMPEDANCES AND THRESHOLDS WERE VARYING OVERNIGHT. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256888 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| L| R ADDRL1 IMPLANTABLE PULSE GENERATOR (IPG)