BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION? 16

    MDR report key: 25272480 · Received May 25, 2026

    Report

    Report Number
    3006630150-2026-03452
    Event Type
    Injury
    Date Received
    May 25, 2026
    Date of Event
    October 29, 2020
    Report Date
    May 25, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729797814
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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-2316-50. SERIAL NUMBER:(B)(6). BATCH/LOT NUMBER: 7081323. MODEL/CATALOG DESCRIPTION: INFINION 16 LEAD KIT 50 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-1432. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 202953. MODEL/CATALOG DESCRIPTION: WAVEWRITER ALPHA PRIME 32 IPG KIT. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2316-50. SERIAL NUMBER:(B)(6). BATCH/LOT NUMBER: 7072118. MODEL/CATALOG DESCRIPTION: INFINION 16 LEAD KIT 50 CM. UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    THE LEAD WAS REPORTED TO HAVE MIGRATED AND EXHIBITED HIGH IMPEDANCE LEVELS. THE PATIENT EXPERIENCED UNWANTED STIMULATION, INCLUDING BURNING SENSATIONS AND PAIN LOCALIZED AT THE BATTERY SITE. PROGRAMMING OPTIMIZATION WAS ATTEMPTED BUT DID NOT RESOLVE THE ISSUE. PATIENT WAS WORKING WITH THE OFFICE TO GET APPROVAL WITH INSURANCE FOR A REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74312 INFINION? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2316-50 7081317 08714729797814

    Patients

    Seq Age Sex Outcome Treatment
    1