BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? PRO

    MDR report key: 21953859 · Received May 2, 2025

    Report

    Report Number
    3006630150-2025-03012
    Event Type
    Injury
    Date Received
    May 2, 2025
    Date of Event
    April 8, 2025
    Report Date
    May 23, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    00191506018733
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC UPN: M365SC14160, MODEL: SC-1416, SERIAL: (B)(6), BATCH: 232273, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN ACTIVE INFECTION DUE TO HEALING IMPAIRMENT AT THE MIDLINE INCISION SITE. THE PATIENT WENT TO ER AND WAS ADMINISTERED IV ANTIBIOTICS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) REPLACEMENT PROCEDURE. NO FURTHER INFORMATION HAD BEEN OBTAINED. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT WAS IMPLANTED WITH A PADDLE LEAD AND A NON-RECHARGEABLE IMPLANTABLE PULSE GENERATOR (IPG). PER PHYSICIAN THIS IS DUE TO PATIENT HAVING A HARD TIME HEALING. THE PATIENT STILL IN THE HOSPITAL AND BEING MONITORED. THE EXPLANTED DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN ACTIVE INFECTION DUE TO HEALING IMPAIRMENT AT THE MIDLINE INCISION SITE. THE PATIENT WENT TO ER AND WAS ADMINISTERED IV ANTIBIOTICS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) REPLACEMENT PROCEDURE. NO FURTHER INFORMATION HAD BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905508 INFINION? PRO STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2318-70 5003672 00191506018733

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Hospitalization| R