BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY IPG

    MDR report key: 7134625 · Received December 20, 2017

    Report

    Report Number
    1627487-2017-08434
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    November 4, 2017
    Report Date
    March 26, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P140009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE EVENT THE DEVICE IS RETURNED TO THE MANUFACTURER, THE REPORTED EVENT CANNOT BE ANALYZED VIA LABORATORY TESTING. THE 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. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 5- REFERENCE MFR REPORT #1627487-2017-08436; REFERENCE MFR REPORT #1627487-2017-08437; REFERENCE MFR REPORT #1627487-2017-08438; REFERENCE MFR REPORT #1627487-2017-08439. ADDITIONAL INFORMATION IDENTIFIED THAT INFECTION SUBSIDED.

    Description of Event or Problem · 1

    DEVICE 1 OF 5. REFERENCE MFR REPORT#1627487-2017-08436, REFERENCE MFR REPORT#1627487-2017-08437, REFERENCE MFR REPORT#1627487-2017-08438, REFERENCE MFR REPORT#1627487-2017-08439. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION (DATE OF INFECTION UNKNOWN, AND CULTURES TAKEN UNKNOWN) AT THE LEAD AND THE IPG (SUBCLAVICLE AREA). PATIENT IS TREATED WITH ANTIBIOTICS AND THE PATIENT IS REPORTEDLY DOING GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913644 INFINITY IPG DBS IPG MHY ST. JUDE MEDICAL - NEUROMODULATION 6662 5887541

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other