BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR

    MDR report key: 22577536 · Received July 23, 2025

    Report

    Report Number
    1627487-2025-03656
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    June 30, 2025
    Report Date
    May 19, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067031426
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07/07/2023-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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 DID NOT RESOLVE 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

    A PATIENT UNABLE TO DISABLE MRI MODE AND ACTIVATE THERAPY WAS REPORTED TO ABBOTT. TROUBLESHOOTING IS PENDING. BASED ON THE INFORMATION RECEIVED, THE EVENT IS CONSISTENT THE LOSS OF THE BLUETOOTH PAIRING BOND WHILE IN MRI MODE.

    Additional Manufacturer Narrative · 0

    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

    ADDITIONAL INFORMATION RECEIVED INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED CONFIRMING AN ABBOTT REPRESENTATIVE MET WITH THE PATIENT AND WAS UNABLE TO SUCCESSFULLY DISABLE THE PATIENT¿S IPG FROM MRI MODE USING AN ORION EXIT TOOL (OET). ADDITIONAL TROUBLESHOOTING WILL BE ATTEMPTED BY THE ABBOTT REPRESENTATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WAS NOT ABLE TO EXIT FROM MRI MODE AFTER AN MRI AND ACTIVATE THERAPY DUE TO DELETING THE EXISTING PARING BOND ON THE PATIENT CONTROLLER. AS SUCH, TROUBLESHOOTING BY A MANUFACTURER REPRESENTATIVE MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED CONFIRMING AN ABBOTT REPRESENTATIVE MET WITH THE PATIENT AND WAS UNABLE TO SUCCESSFULLY DISABLE THE PATIENT¿S IPG FROM MRI MODE USING A SECOND ORION EXIT TOOL (OET).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374071 PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG LGW ABBOTT MEDICAL 3662 T00005580 05415067031426

    Patients

    Seq Age Sex Outcome Treatment
    1