BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR

    MDR report key: 23788786 · Received December 12, 2025

    Report

    Report Number
    1627487-2025-06122
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 6, 2025
    Report Date
    March 31, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067020215
    PMA / PMN Number
    P150004
    Removal / Correction Number
    1627487-07/07/2023-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PATIENT UNABLE TO DISABLE MRI MODE AND ACTIVATE THERAPY WAS REPORTED TO ABBOTT. THE OET WAS SUCCESSFUL IN REMOVING PATIENTS IPG FROM MRI MODE RESOLVING THE ISSUE. BASED ON THE INFORMATION RECEIVED, THE EVENT IS CONSISTENT WITH THE LOSS OF THE BLUETOOTH PAIRING BOND WHILE IN MRI MODE. AS A RESULT OF THIS FINDING, ABBOTT IS PERFORMING FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS 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 THAT FOLLOWING AN MRI ON (B)(6) 2025 WHERE THE DEVICE WAS PLACED INTO MRI MODE, THE PATIENT WAS UNABLE TO DISABLE MRI MODE. AN ABBOTT REPRESENTATIVE MET WITH THE PATIENT AND WAS ABLE TO SUCCESSFULLY DISABLE THE PATIENT¿S IPG FROM MRI MODE 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 RESTORE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2769381 PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR DRG IPG PMP ABBOTT MEDICAL 3664 T00005576 05415067020215

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male DRG LEAD.| DRG LEAD.