BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1803289 · Received August 17, 2010

    Report

    Report Number
    2649622-2010-08822
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    June 2, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    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. THE SPRINT FIDELIS LEAD MODEL IS INCLUDED IN A FIELD ADVISORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME TO AN UNSCHEDULED FOLLOW-UP BECAUSE HE HEARD THE PATIENT ALERT EVERY 4 HOURS (LIA). THE OBSERVATION AT THE FOLLOW UP WAS: MUCH SHORT V-V INTERVALS AND THE COUNTER GOES UP TO THE ALERT THRESHOLD. THE OTHER VALUES WERE STABLE AND IN RANGE SINCE IMPLANTATION. THE RIGHT VENTRICULAR (RV) PARAMETER WAS PROGRAMMED TO SENSING PATH RVTIP/RVRING. WHEN PATIENT MOVES HIS ARMS, THEN SOME SHORT VV-INTERVALS COULD BE SEEN ON PROGRAMMER SCREEN. THE PHYSICIAN DECIDED TO CHANGE THE PROGRAMMED RV SENSING PARAMETER TO RVTIP/RVCOIL AND TAKES THE SENSITIVITY THRESHOLD UP TO 0,6 MV (SENSING WAS >15MV). PATIENT MOVES A LOT AFTER THIS PROCEDURE AND NO SHORT VV-INTERVALS COULD BE OBSERVED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5076 IMPLANTABLE PACING LEAD| D284DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB