BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4162922 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12559
    Event Type
    Injury
    Date Received
    October 10, 2014
    Report Date
    July 17, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    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 MEDICAL PRODUCTS: A 5076-52 LEAD:M (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA (VT) DUE TO UNDERSENSING AND OVERPACING IN THE VENTRICLE. ADDITIONALLY, ONE DAY POST THE PATIENT'S DEVICE CHANGEOUT, THE CHRONIC RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS WERE FOUND TO HAVE DISLODGED. THERE WAS INTERMITTENT UNDERSENSING ON BOTH LEADS. THE RA LEAD SHOWED NO CAPTURE AND THE RV LEAD SHOWED INTERMITTENT CAPTURE. THE PHYSICIAN WAS OFFERED NEW LEADS TO IMPLANT HOWEVER, THE PHYSICIAN OPTED TO EXPLANT AND RE-IMPLANT THE CHRONIC LEADS. USING FLUOROSCOPY, THE LEADS WERE PLACED. SUFFICIENT SENSING AND THRESHOLDS WERE OBTAINED UPON REPOSITIONING/LEAD REVISION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD HAD DISLODGED ONCE AGAIN. IT WAS NOTED THAT THE LEAD EXHIBITED NO CAPTURE OF ATRIAL AT HIGH OUTPUTS AND UNDERSENSING. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639183 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R