BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3860394 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05452
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    February 26, 2014
    Report Date
    March 7, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT VISUAL SUMMARY ANALYSIS OF THE LEAD WAS PERFORMED. A PROXIMAL PORTION WAS RECEIVED MEASURING 6.5 CM.

    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: 429688 LEAD, IMPLANTED: (B)(6) 2014. A 6935M62 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE AND RA LEAD WERE LATER EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE IMPLANT PROCEDURE AND POST DFT TESTING, THE RIGHT ATRIAL (RA) LEAD DROPPED INTO THE VENTRICLE. THE RA LEAD WAS LATER REPOSITIONED AND REMAINS IN USE. IT WAS ALSO REPORTED THAT A FEW DAYS AFTER THE RA LEAD REVISION, THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE INCREASED AND EVENTUALLY THERE WAS AN RV HIGH IMPEDANCE ALERT. THE POCKET WAS RE-OPENED AND IT WAS DETERMINED THAT THE DEVICE SETSCREW WAS LOOSE. THE SETSCREW WAS TIGHTENED AND THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343255 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization| R DTBA1D4 BIV ICD