BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 2812399 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16676
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Adverse Event
    Yes
    Product Problem
    Yes
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM BECAUSE THEY WERE NOT FEELING WELL. IT WAS NOTED FROM TREND DATA THAT THE LEAD HAD A HIGH PACING THRESHOLD FROM THE TIME OF INITIAL IMPLANT. IT WAS SUSPECTED THAT THE LEAD WAS NOT FIXED AT THE APPROPRIATE POSITION. THE LEAD WAS EXPLANTED AND REPLACED. BECAUSE IT WAS POSSIBLE TO REMOVE THE LEAD VERY EASILY, THE CAUSE OF THE EVENT WAS CONCLUDED TO BE INCOMPLETE FIXATION OF THE LEAD TIP. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE Z NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5054

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R 5554 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR