BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY IPG

    MDR report key: 7126368 · Received December 18, 2017

    Report

    Report Number
    1627487-2017-08348
    Event Type
    Injury
    Date Received
    December 18, 2017
    Date of Event
    November 23, 2017
    Report Date
    December 18, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P140009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED (AUSTRALIA) THE PATIENT UNDERWENT SURGICAL INTERVENTION TO BURY THE IPG DEEPER AS THE PATIENT LOST WEIGHT. HOWEVER DURING THE SURGERY THE IPG WAS UNABLE TO ESTABLISH COMMUNICATION WITH THE EXTERNAL DEVICES AND DEEMED INOPERABLE. THE IPG WAS EXPLANTED AND REPLACED WITH ANOTHER MODEL WHICH RESOLVED THE ISSUE. THE PATIENT IS DOING ¿FINE¿. DEVICE INFORMATION IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904026 INFINITY IPG DBS IPG MHY ST. JUDE MEDICAL - NEUROMODULATION 6662

    Patients

    Seq Age Sex Outcome Treatment
    1 Other