BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? PRO

    MDR report key: 24581494 · Received March 12, 2026

    Report

    Report Number
    3006630150-2026-01454
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    February 19, 2026
    Report Date
    May 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    00191506018733
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2318-70, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 5007688, MODEL/CATALOG DESCRIPTION: INFINION PRO LEAD KIT, 16 CONTACT, 70CM, UNIQUE IDENTIFIER (UDI)#: (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-1232, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 802710, MODEL/CATALOG DESCRIPTION: WAVEWRITER ALPHA 32 IPG KIT, UNIQUE IDENTIFIER (UDI)#: (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-4318, BATCH/LOT NUMBER: 37825206, MODEL/CATALOG DESCRIPTION: CLIK X ANCHOR STERILE KIT, UNIQUE IDENTIFIER (UDI)#: (B)(4). BLOCK D2B: PRO CODE (PRODUCT CODE): QRB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE MIDLINE INCISION SITE WHICH CAUSED FEVER, DRAINAGE, REDNESS AND IMPAIRED HEALING AT THE INCISION SITE. THE PATIENT WAS PROVIDED WITH PROPHYLACTIC ANTIBIOTICS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) LEAD EXPLANT PROCEDURE, WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE KEPT BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571575 INFINION? PRO STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2318-70 5006441 00191506018733

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention