BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR

    MDR report key: 21473151 · Received February 26, 2025

    Report

    Report Number
    3006705815-2025-01343
    Event Type
    Malfunction
    Date Received
    February 26, 2025
    Date of Event
    January 16, 2024
    Report Date
    May 6, 2025
    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
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED TO ABBOTT A PATIENT WAS UNABLE TO CONNECT WITH THEIR IPG. THE PATIENT CONTROLLER (PC) APP DISPLAYED: "GENERATOR IS NO LONGER PAIRED WITH THIS DEVICE." THE PATIENT HAD AN MRI. THE PATIENT STATED MRI MODE WAS ENABLED BUT THEY DO NOT BELIEVE IT WAS DISABLED. PATIENT REPORTED NO SURGERIES. THE REP WAS UNABLE TO CONNECT WITH HIS CLINICIAN PROGRAMMER. TS REQUESTED CP LOGS. THE LOGS SHOWED THE IPG NEVER ENTERED BONDABLE STATE. THE REP MET WITH THE PATIENT AND RECOVERED THE DEVICE USING THE OET TOOL. ACCESS TO THERAPY WAS RESTORED. BASED ON THE INFORMATION RECEIVED, THE IPG IS FUNCTIONING AS INTENDED AND THE CAUSE OF THE REPORTED ISSUE IS CONSISTENT WITH LEAVING MRI OR SURGERY MODE ACTIVATED AFTER AN ACTIONS HAVE BEEN TAKEN TO PREVENT REOCCURRENCE.

    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.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. 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 WHERE THE DEVICE WAS PLACED INTO 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 CLINICIAN PROGRAMMER WERE ABLE TO BOND WITH THE IPG, AND RESTORED THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249139 PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3660 A000118368 05415067031419

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SCS LEAD