BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM PLUS IMPLANTABLE PULSE GENERATOR

    MDR report key: 25196143 · Received May 17, 2026

    Report

    Report Number
    3006705815-2026-03095
    Event Type
    Injury
    Date Received
    May 17, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067046383
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07/07/2023-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. BASED ON INFORMATION OBTAINED THE DEVICE IS INCLUDED IN THE NEUROMODULATION IMPLANTABLE PULSE GENERATOR (IPG) UNABLE TO EXIT MRI MODE ADVISORY NOTICE ISSUED BY ABBOTT ON 22 JUNE 2023.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WAS NOT ABLE TO EXIT FROM MRI MODE AFTER AN MRI. AS A RESULT, AN ABBOTT REPRESENTATIVE PLANS TO MEET WITH THE PATIENT AND TROUBLESHOOT USING AN ORION EXIT TOOL (OET).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING AN ABBOTT REPRESENTATIVE MET WITH THE PATIENT AND WAS ABLE TO SUCCESSFULLY DISABLE THE PATIENT¿S IPG FROM MRI MODE WITHOUT USING AN ORION EXIT TOOL (OET). ONCE THE IPG WAS TAKEN OUT OF MRI MODE, THE PATIENT CONTROLLER AND/OR CLINICIAN PROGRAMMER WAS ABLE TO BOND WITH THE IPG, AND RESTORED THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163128 PROCLAIM PLUS IMPLANTABLE PULSE GENERATOR SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3670 A000144439 05415067046383

    Patients

    Seq Age Sex Outcome Treatment
    1