BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? PRO

    MDR report key: 24622248 · Received March 17, 2026

    Report

    Report Number
    3006630150-2026-01572
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    November 10, 2025
    Report Date
    April 6, 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
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: LGW, QRB ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2318-70 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5003840 MODEL/CATALOG DESCRIPTION: INFINION PRO LEAD KIT, 16 CONTACT, 70CM UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2318-70 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5004195 MODEL/CATALOG DESCRIPTION: INFINION PRO LEAD KIT, 16 CONTACT, 70CM UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2318-70 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5004141 MODEL/CATALOG DESCRIPTION: INFINION PRO LEAD KIT, 16 CONTACT, 70CM UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE H11 THE SUSPECTED MEDICAL DEVICE REPORTED IN THIS MDR FORM SHOULD HAVE BEEN REPORTED ON A 3500A MDR FORM. MODEL NUMBER/CATALOG NUMBER: SC-1232 SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 783722, MODEL/CATALOG DESCRIPTION: WAVEWRITER ALPHA 32 IPG KIT, UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING UNWANTED STIMULATION AND LEAD MIGRATED. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) REPLACEMENT PROCEDURE. THE PATIENT WAS PROGRAMMED STIMULATION TO COVER ALL PAINFUL AREAS. THE EXPLANTED DEVICES WILL NOT BE RETURNED PER FACILITY POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING UNWANTED STIMULATION AND LEAD MIGRATED. THE PATIENT UNDERWENT SPINAL CORD STIMULATION (SCS) REPLACEMENT PROCEDURE. THE PATIENT WAS PROGRAMMED STIMULATION TO COVER ALL PAINFUL AREAS. THE EXPLANTED DEVICES WILL NOT BE RETURNED PER FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680607 INFINION? PRO STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2318-70 5003877 00191506018733

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention