BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ MRI IPG

    MDR report key: 6077030 · Received November 3, 2016

    Report

    Report Number
    3006705815-2016-00549
    Event Type
    Injury
    Date Received
    November 3, 2016
    Report Date
    October 7, 2016
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SJM 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. SJM DEFERS TO THE PATIENT¿S PHYSICIAN REGARDING MEDICAL HISTORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED DISCOMFORT AT THE IPG SITE DUE TO THE LOCATION OF THE IPG. AS A RESULT, THE IPG WAS MOVED TO A DIFFERENT LOCATION ON (B)(6) 2016. THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727509 PROTÉGÉ MRI IPG SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3771 5180382

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL: 3228, SCS LEAD| MODEL: 3386 (X2), SCS EXTENSIONS