BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 20037444 · Received August 22, 2024

    Report

    Report Number
    3006630150-2024-05483
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    March 3, 2024
    Report Date
    September 20, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 5113529 / 5113749.

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A WEEK PRIOR TO (B)(6) 2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INCREASING PAIN AROUND THE SPINAL CORD STIMULATOR (SCS) DEVICE. THE PAIN WAS CONSISTENT AND FELT LIKE A BURNING SENSATION AND SWELLING OVER THE TOP OF THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT WAS PRESCRIBED PAIN MEDICATIONS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN SCS SYSTEM EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INCREASING PAIN AROUND THE SPINAL CORD STIMULATOR (SCS) DEVICE. THE PAIN WAS CONSISTENT AND FELT LIKE A BURNING SENSATION AND SWELLING OVER THE TOP OF THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT WAS PRESCRIBED PAIN MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219374 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 350492 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention