BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR

    MDR report key: 21337827 · Received February 7, 2025

    Report

    Report Number
    3006705815-2025-00856
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    January 3, 2025
    Report Date
    March 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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. TROUBLESHOOTING STEPS RESOLVED THE ISSUE AND THERAPY WAS REESTABLISHED. 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

    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

    ADDITIONAL INFORMATION RECEIVED INDICATES, TROUBLESHOOTING WAS DONE WITH ORION EXIT TOOL (OET) AND THE IPG WAS SUCCESSFULLY EXITED OUT OF MRI MODE. THERAPY HAD BEEN RESTORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SET THEIR IPG TO MRI MODE PRIOR TO AN MRI. PATIENT IS UNSURE IF THEY DISABLED MRI MODE FOLLOWING THE MRI. THE IPG IS CURRENTLY UNABLE TO COMMUNICATE WITH THE EXTERNAL DEVICES. AS A RESULT, TROUBLESHOOTING MAY TAKE PLACE USING AN ORION EXIT TOOL (OET) AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526585 PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3660 A000121543 05415067031419

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female SCS ANCHOR (X2)| SCS LEAD (X2)