BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3993174 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09441
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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, IMPLANTED: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL AND RV (RIGHT VENTRICULAR) LEADS WERE PULLED BACK INTO THE SVC (SUPERIOR VENA CAVA) DUE TO TWIDDLER'S SYNDROME. THE LEADS WERE EXPLANTED. THE PHYSICIAN IMPLANTED A NEW RV LEAD WITH NO COMPLICATIONS. DURING IMPLANT ATTEMPT OF THE NEW ATRIAL LEAD, AFTER INITIAL PLACEMENT IN THE ATRIUM THE PHYSICIAN REMOVED THE STYLET FROM THE LEAD AND ATTEMPTED TO PLACE ANOTHER STYLET FOR LEAD MANIPULATION. AFTER SEVERAL ATTEMPTS AND SEVERAL STYLETS, THE PHYSICIAN COULD NOT GET A STYLET TO CANNULATE PAST ABOUT 3/4 DOWN THE LEAD. THE LEAD WAS NOT USED AND ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467914 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4592-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R 407452 LEAD