BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3861272 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07336
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 MEDICAL PRODUCTS: A 5076-52 LEAD: (B)(6) 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED AND A LONGER LEAD WAS IMPLANTED IN ITS PLACE. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DISLODGED. A REVISION WAS DONE AND THE LEAD REMAINS IN USE. IT WAS NOTED THAT THE PATIENT'S LEADS DISLODGED DUE TO "TWIDDLERS SYNDROME". IT WAS ALSO REPORTED THAT THERE WAS NERVE AND DIAPHRAGMATIC STIMULATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340485 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 559445

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R ADDR01 IPG