BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER?

    MDR report key: 22014706 · Received May 13, 2025

    Report

    Report Number
    3006630150-2025-03308
    Event Type
    Injury
    Date Received
    May 13, 2025
    Date of Event
    September 9, 2020
    Report Date
    May 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED TWO WEEKS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8336700, MODEL: SC-8336-70, SERIAL: (B)(6), BATCH: 5181129, UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION: UPN: M365SC43160, MODEL: SC-4316, BATCH: 24068769, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED AN INFECTION. SYMPTOMS OF REDNESS, SWELLING, AND PAIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE WAS NOTED. THE PHYSICIAN BELIEVED IT WAS NOT PROCEDURE OR DEVICE RELATED, AND THE CAUSE WAS UNKNOWN. THE PATIENT UNDERWENT EXPLANT PROCEDURE. THE PATIENT WAS ADMINISTERED ANTIBIOTIC PROPHYLACTICALLY. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241991 SPECTRA WAVEWRITER? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1160 366538 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Required Intervention