BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 3994304 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-02004
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    October 19, 2009
    Report Date
    February 28, 2010
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    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 THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. A ECHO CARDIOGRAM REVEALED DETERIORATION HAD OCCURRED. THE PATIENT ALSO HAD HISTORY OF CHEST PAIN AND INDICATION OF CORONARY ARTERY DISEASE (CAD). HOWEVER, ANGIOGRAM REVEALED NO CAD EXISTED. INSTEAD, IMPAIRED LEFT VENTRICULAR FUNCTION WAS PRESENT. AS A RESULT AND DUE TO PATIENT CONDITION THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND A SYSTEM UPGRADE WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THIS PATIENT IS A PARTICIPANT OF THE PROTECT-PACE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467666 SENSIA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Hospitalization| R