BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2813139 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16724
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 20, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 EXPERIENCED CHEST PAIN DURING THE IMPLANTING PROCEDURE. THE PATIENT WAS HOSPITALIZED FOR THE IMPLANT AND THE HOSPITALIZATION WAS PROLONGED DUE TO CARDIAC TAMPONADE. A CARDIAC DRAIN WAS PLACED AND PERICARDIAL EFFUSION WAS SEEN ON ECHOCARDIOGRAM. THE CARDIAC TAMPONADE WAS DUE TO IMPLANT PROCEDURE RELATED NOT SYSTEM RELATED. THE LEAD REMAINS IN USE. THE PATIENT IS ENROLLED 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
    1 SPRINT QUATTRO SECURE S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R D354TRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| COMPETITOR X2 IMPLANTABLE PACING LEADS