BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ MRI IPG

    MDR report key: 18049206 · Received November 1, 2023

    Report

    Report Number
    3006705815-2023-07068
    Event Type
    Injury
    Date Received
    November 1, 2023
    Date of Event
    September 19, 2023
    Report Date
    November 28, 2023
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067017086
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    DAE OF EVENT IS ESTIMATED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATES THE IPG WAS REPLACED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT LOST THERAPY DUE TO IPG BEING INOPERABLE. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932277 PROTÉGÉ MRI IPG SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3771 5389048 05415067017086

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SCS LEAD