BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR

    MDR report key: 20781865 · Received November 26, 2024

    Report

    Report Number
    3006705815-2024-08945
    Event Type
    Injury
    Date Received
    November 26, 2024
    Date of Event
    November 1, 2024
    Report Date
    March 18, 2025
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067031419
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT THAT IPG WAS REVISED DUE TO DISPLAYING ¿REPLACE GENERATOR SOON¿ IMAGE AND WAS END OF SERVICE (EOS) WAS CONFIRMED. ANALYSIS AND A LONGEVITY CALCULATION OF THE RETURNED IPG FOUND THE DEVICE HAD DISPLAYED THE ¿REPLACE GENERATOR SOON¿ IMAGE AS REPORTED, CLAIMED EOS AND HAD NORMAL BATTERY DEPLETION DUE TO USAGE.

    Additional Manufacturer Narrative · 0

    B3-DATE OF EVENT IS ESTIMATED.

    Description of Event or Problem · 0

    IT WAS REPORTED PC DISPLAYED THE MESSAGE 'REPLACE GENERATOR'. IT IS UNKNOW IF THE IPG DEPLETED EARLIER. SURGICAL INTERVENTION IS PENDING TO ADDRESS THE ISSUE AT A LATER TIME.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THE IPG WAS INOPERABLE, AND PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE IPG WAS REPLACED AND THERAPY RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2441767 PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3660 A000146457 05415067031419

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Other SCS LEAD (1)