BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 24615848 · Received March 17, 2026

    Report

    Report Number
    3006630150-2026-01554
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    January 1, 2024
    Report Date
    May 6, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE APPROXIMATED, EVENT OCCURRED IN 2024. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2317-50 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7071636 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: 7071619 MODEL/CATALOG DESCRIPTION: INFINION CX LEAD KIT, 50CM UNIQUE IDENTIFIER (UDI)#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS FREQUENTLY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG) AND HIGH IMPEDANCES WERE ALSO NOTED ON TWO CONTACTS ON ONE OF THE SPINAL CORD STIMULATOR (SCS) LEADS. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND LEADS WERE REPLACED AND THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110261 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 369370 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1