BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR

    MDR report key: 21607686 · Received March 14, 2025

    Report

    Report Number
    3006705815-2025-01850
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    February 24, 2025
    Report Date
    September 10, 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
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. THE DEVICE IS INCLUDED IN THE NEUROMODULATION IMPLANTABLE PULSE GENERATOR (IPG) UNABLE TO EXIT MRI MODE ADVISORY NOTICE ISSUED BY ABBOTT ON (B)(6) 2023.

    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 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 STEPS DID NOT RESOLVE THE ISSUE. THE IPG WAS REPLACED TO REESTABLISH THERAPY. BASED ON THE INFORMATION RECEIVED, THE EVENT IS CONSISTENT WITH THE LOSS OF THE BLUETOOTH PAIRING BOND WHILE IN MRI MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S IPG WAS SET TO MRI MODE, BUT THE PATIENT IS UNSURE IF THE IPG WAS EXITED OUT OF MRI MODE. PATIENT'S IPG IS CURRENTLY NOT COMMUNICATING WITH THE EXTERNAL DEVICES, AND THE PATIENT IS UNABLE TO EXIT MRI MODE. TROUBLESHOOTING ATTEMPT WAS MADE WITH ORION EXIT TOOL (OET) BY ABBOTT REPRESENTATIVE, BUT THE ISSUE WAS UNABLE TO BE RESOLVED. FURTHER TROUBLESHOOTING MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT ISSUE WAS RESOLVED WITH FURTHER TROUBLE SHOOTING WITH OET TOOL. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. REPORTEDLY, THERAPY WAS RESTORED POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229152 PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3660 A000155271 05415067031419

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other SCS ANCHOR (X2).| SCS LEAD (X2).