BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR

    MDR report key: 20724345 · Received November 19, 2024

    Report

    Report Number
    3006705815-2024-08772
    Event Type
    Injury
    Date Received
    November 19, 2024
    Date of Event
    October 29, 2024
    Report Date
    June 10, 2025
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067031426
    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
    IN, 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 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

    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 22 JUNE 2023.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H1 - TYPE OF REPORTABLE EVENT UPDATED TO SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE REPORTED OBSERVATION OF ¿UNABLE TO DISABLE MRI MODE¿ WAS CONFIRMED. THE ROOT CAUSE FOR THE INABILITY TO ESTABLISH COMMUNICATION BETWEEN THE PROGRAMMER/ORION EXIT TOOL (OET) AND THE IMPLANTABLE PULSE GENERATOR (IPG) WAS DUE TO THE DEVICE HAVING NORMAL BATTERY DEPLETION WHILE IN MRI MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SET THE IPG INTO MRI MODE AND IS NOW UNABLE TO EXIST MRI MODE DUE TO LOSING THEIR PATIENT CONTROLLER. TROUBLESHOOTING 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 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. REPORTEDLY, THERAPY WAS RESTORED POST OPERATIVE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323088 PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3662 A000120406 05415067031426

    Patients

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