BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3991428 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08137
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    July 30, 2013
    Report Date
    May 7, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    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 PRODUCT: 6947-65 LEAD IMPLANTED: (B)(6) 2002. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT FOR HIGH IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD WAS ISSUED. THE RV AND THE SUPERIOR VENA CAVA (S VC) COIL WERE BOTH FOUND TO HAVE HIGH IMPEDANCE WITH A SUSPECT OF A POSSIBLE FRACTURE. THE RV LEAD WAS CAPPED AND A NEW LEAD WAS IMPLANTED. IT WAS FURTHER REPORTED THAT DURING DEVICE CHANGE OUT, THE RIGHT ATRIAL (RA) LEAD HAD DISLODGED. THE RA LEAD WAS EXTRACTED AND NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470612 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 559453

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Hospitalization| R D154AWG ICD