BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 18703109 · Received February 14, 2024

    Report

    Report Number
    3006630150-2024-00672
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    October 30, 2023
    Report Date
    February 14, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT BRAND NAME: LINEAR 3-6. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 7080195. BRAND NAME: LINEAR 3-6. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(6). BATCH: 7080136.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD NEVER EXPERIENCED PAIN REDUCTION FROM THE SPINAL CORD STIMULATION (SCS) SYSTEM. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE ENTIRE SYSTEM. DURING THE PROCEDURE A NON-BOSTON SCIENTIFIC ELECTRODE WAS ALSO EXPLANTED. THE PHYSICIAN NOTED THAT DURING THE EXPLANT PROCEDURE, PUS SECRETION WAS NOTED IN THE IPG POCKET, AND ASSESSED THAT THE INFECTION WAS NOT DEVICE RELATED. THERE WERE NO PATIENT COMPLICATIONS. THE EXPLANTED PRODUCT WILL NOT BE RETURNED AS IT WAS RETAINED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284211 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 570814 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention