BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR

    MDR report key: 25136210 · Received May 11, 2026

    Report

    Report Number
    3006705815-2026-02906
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 11, 2026
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067031419
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07/07/2023-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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.

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48455 PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3660 A000152773 05415067031419

    Patients

    Seq Age Sex Outcome Treatment
    1