BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR

    MDR report key: 15530462 · Received October 3, 2022

    Report

    Report Number
    3006705815-2022-17181
    Event Type
    Injury
    Date Received
    October 3, 2022
    Date of Event
    September 19, 2022
    Report Date
    December 19, 2022
    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
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED.

    Additional Manufacturer Narrative · 0

    A PATIENT EXPERIENCED PAIN AT THE IPG DUE TO POSSIBLE INFECTION WAS REPORTED TO ABBOTT. IT WAS DETERMINED THE IPG WAS ERODING THE SKIN. THE PATIENT WAS TREATED WITH PROPHYLACTIC ANTIBIOTICS AND THE PHYSICIAN ORDERED NPO AND AN INCISION AND DRAINAGE PROCEDURE. THE INFECTION WAS RULED OUT AND THE ISSUE WAS RESOLVED. 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

    IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AT THE IPG DUE TO POSSIBLE INFECTION. REPORTEDLY, THE IPG WAS ERODING THE SKIN. PATIENT WAS TREATED WITH PROPHYLACTIC ANTIBIOTICS AND THE PHYSICIAN ORDERED NPO AND AN INCISION AND DRAINAGE PROCEDURE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED IDENTIFIED THAT INFECTION WAS RULED OUT AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2075454 PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3660 A000103522 05415067031419

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SCS ANCHOR X2| SCS LEAD X2