BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 24960629 · Received April 22, 2026

    Report

    Report Number
    3006630150-2026-02561
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 22, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2317-50 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5014193 MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2317-50 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 5039034 MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) SYSTEM WAS EXPLANTED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168626 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 366612 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1