BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSIA DR

    MDR report key: 3994280 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-02009
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    September 11, 2009
    Report Date
    October 1, 2009
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    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 ONE DAY AFTER THE IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) THE PATIENT EXPERIENCED CHEST PAIN AND A LEFT SIDE PNEUMOTHORAX WAS CONFIRMED VIA CHEST X-RAY. A CHEST DRAIN WAS INSERTED TO RESOLVE THE PNEUMOTHORAX AND SUBSEQUENTLY THE PATIENT DEVELOPED A FEVER AND INCREASED INFLAMMATORY MARKERS AND WAS TREATED WITH ANTIBIOTICS. THE DEVICE REMAINS IN USE. THE PATIENT WAS ENROLLED IN THE PROTECT-PACE CLINICAL 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
    468659 SENSIA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Life Threatening| R