BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE

    MDR report key: 3994277 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10109
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    March 2, 2009
    Report Date
    March 25, 2009
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT ONE MONTH AFTER THE IMPLANT PROCEDURE, THE PATIENT EXPERIENCED PAIN AND NIGHT SWEATS. PERICARDITIS WAS NOTED, WHICH WAS EXACERBATED BY THE LEFT VENTRICULAR (LV) LEAD. ORAL MEDICATION WAS GIVEN TO RESOLVE THE PAIN AND THE DEVICE - WHICH WAS FUNCTIONING NORMALLY - WAS EXPLANTED TO ALLOW THE PERICARDITIS TO RESOLVE AND THEN IT WAS REPLACED. THE LV LEAD REMAINS IN USE. THE PATIENT WAS A PARTICIPANT IN THE (B)(6) STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468541 SELECTSECURE DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 383069

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Hospitalization| R SEDRL1 IPG