BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR

    MDR report key: 18628476 · Received February 1, 2024

    Report

    Report Number
    3006705815-2024-00902
    Event Type
    Injury
    Date Received
    February 1, 2024
    Date of Event
    January 3, 2024
    Report Date
    February 20, 2024
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067031419
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS ESTIMATED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: LEAD, MODEL: 1192, UDI: (B)(4), SERIAL: N/A, BATCH: 8874960.

    Additional Manufacturer Narrative · 0

    A PATIENT EXPERIENCED PAIN AT THE ANCHOR SIDE WAS REPORTED TO ABBOTT. IT WAS DETERMINED THAT DURING A SURGICAL INTERVENTION PROCEDURE, A FLUID DISCHARGE WAS NOTICED AT THE IPG POCKET AND INCISION SIDES. AS A RESULT, THE PHYSICIAN OPTED TO EXPLANT THE ENTIRE SYSTEM TO ADDRESS THE ISSUE. AS A RESULT, A DEVICE HISTORY RECORD WAS PERFORMED TO REVIEW AND CONFIRM THE STERILITY OF DEVICES. BASED ON THE DOCUMENTS REVIEWED, THE SOURCE OF THE INFECTION REMAINS UNKNOWN.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER 1627487-2024-00592, RELATED MANUFACTURER REFERENCE NUMBER 3006705815-2024-00901, RELATED MANUFACTURER REFERENCE NUMBER 3006705815-2024-00903. IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AT THE ANCHOR SIDE. DURING A SURGICAL INTERVENTION PROCEDURE, A FLUID DISCHARGE WAS NOTICED AT THE IPG POCKET AND INCISION SIDES. AS A RESULT, THE PHYSICIAN OPTED TO EXPLANT THE ENTIRE SYSTEM TO ADDRESS THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE THE ANCHOR THAT WAS ASSOCIATED WITH THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249328 PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3660 A000139073 05415067031419

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SCS ANCHOR.