BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 S

    MDR report key: 4160807 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02351
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 DURING AN OFFICE VISIT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD NO TELEMETRY WITH TWO DIFFERENT PROGRAMMERS AND NO MAGNET RESPONSE; PACING WAS ABSENT. THE IPG WAS EXPLANTED AND NOT REPLACED DUE TO PATIENT'S CONDITION AND AGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642242 SIGMA 300 S PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SS303U

    Patients

    Seq Age Sex Outcome Treatment
    1 00094 YR Hospitalization| R