BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 3994263 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-02006
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    September 30, 2011
    Report Date
    July 24, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    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 EXPERIENCED CHEST PAIN AND TACHYCARDIA DUE TO THE DEVICE TRACKING ATRIAL FLUTTER. THE PATIENT'S TROPONIN LEVEL WAS RAISED DUE TO THE TACHYCARDIA. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT WAS A PARTICIPANT IN THE PROTECT-PACE 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
    467036 SENSIA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SEDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Life Threatening| R