BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2130458 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10165
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    April 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH THRESHOLDS, AND WAS FOUND TO HAVE DISLODGED. THE LEAD WAS REPOSITIONED, AND REMAINS IN USE. DURING THE REPOSITIONING, THE DEVICE WAS REPROGRAMMED IN ORDER TO EXPOSE THE PATIENT'S UNDERLYING RHYTHM, AND WHEN THE PROCEDURE WAS COMPLETE, A MAGNET WAS APPLIED TO THE DEVICE IN ORDER TO DETERMINE DEVICE FUNCTION. HOWEVER, THE MAGNET RATE HAD BEEN DISABLED FOR A PERIOD OF TIME FOLLOWING PROGRAMMER INTERACTION, AND THE DEVICE WAS THOUGHT TO BE FAULTY. THE DEVICE WAS EXPLANTED AND REPLACED, AND WHEN LATER TESTED, PERFORMED NORMALLY. THE CLINICIANS WERE NOT HAPPY THAT THEY WERE UNAWARE OF THIS FEATURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5092 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R