BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ MRI IPG

    MDR report key: 9271858 · Received November 4, 2019

    Report

    Report Number
    3006705815-2019-04254
    Event Type
    Injury
    Date Received
    November 4, 2019
    Date of Event
    May 10, 2019
    Report Date
    November 4, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067017086
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT #1 PI MAIN [PI-2019-0103647-01]. A PATIENT EXPERIENCING AUTOREDUCING DUE TO HIGH IMPEDANCE WAS REPORTED TO ABBOTT. IT WAS DETERMINED THAT THE LEAD HAD PULLED OUT OF THE HEADER AND OUTER SPACE. INTERVENTION IS NOT YET PLANNED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICES WERE NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. PRODUCT #2 PI MAIN [PI-2019-0103647-03]. A PATIENT EXPERIENCING AUTOREDUCING DUE TO HIGH IMPEDANCE WAS REPORTED TO ABBOTT. IT WAS DETERMINED THAT THE LEAD HAD PULLED OUT OF THE HEADER AND OUTER SPACE. INTERVENTION IS NOT YET PLANNED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICES WERE NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. PRODUCT #3 PI MAIN [PI-2019-0103647-02]. A PATIENT EXPERIENCING AUTOREDUCING DUE TO HIGH IMPEDANCE WAS REPORTED TO ABBOTT. IT WAS DETERMINED THAT THE LEAD HAD PULLED OUT OF THE HEADER AND OUTER SPACE. INTERVENTION IS NOT YET PLANNED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICES WERE NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. PRODUCT #4 PI MAIN [PI-2019-0103647-04]. A PATIENT EXPERIENCING AUTOREDUCING DUE TO HIGH IMPEDANCE WAS REPORTED TO ABBOTT. IT WAS DETERMINED THAT THE LEAD HAD PULLED OUT OF THE HEADER AND OUTER SPACE. INTERVENTION IS NOT YET PLANNED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICES WERE NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-12234, 1627487-2019-12235, 1627487-2019-12236. IT WAS REPORTED THAT THE PATIENT HAD AUTOREDUCING DUE TO HIGH IMPEDANCES. THE PATIENT HAD THEIR SCS SYSTEM EXPLANTED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066920 PROTÉGÉ MRI IPG SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3771 5305920 05415067017086

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other MODEL 3228 SCS LEAD| MODEL 3228 SCS LEAD| MODEL 3771 SCS IPG