BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA? 16

    MDR report key: 22297584 · Received June 20, 2025

    Report

    Report Number
    3006630150-2025-04704
    Event Type
    Injury
    Date Received
    June 20, 2025
    Date of Event
    April 9, 2025
    Report Date
    October 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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: 7160915, UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7160908, UDI: (B)(4). PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43180, MODEL: SC-4318, BATCH: 35716616, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    SC-1216 (SN: (B)(6)). THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. SC-2218-50 (SN: (B)(6)). THE RETURNED LEADS WERE ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. SC-4318 (LN: 35716616) THE RETURNED LEADS WERE ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IT WAS ALSO NOTED THAT THE PATIENT HAD STAPHYLOCOCCUS INFECTION. SYMPTOMS OF PAIN, INFLAMMATION, SWELLING, AND IMPAIRED HEALING AT THE POCKET SITE WERE NOTED. A LARGE AMOUNT OF FLUID WAS DRAINED FROM THE FLANK INCISION AND IT WAS SEROSANGUINOUS IN NATURE. THE PHYSICIAN BELIEVED THAT THE ISSUES WERE DEVICE RELATED. THE PATIENT WAS ADMINISTERED WITH ANTIBIOTICS AND UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF. IT WAS ALSO NOTED THAT THE PATIENT HAD STAPHYLOCOCCUS INFECTION. SYMPTOMS OF PAIN, INFLAMMATION, SWELLING, AND IMPAIRED HEALING AT THE POCKET SITE WERE NOTED. A LARGE AMOUNT OF FLUID WAS DRAINED FROM THE FLANK INCISION AND IT WAS SEROSANGUINOUS IN NATURE. THE PHYSICIAN BELIEVED THAT THE ISSUES WERE DEVICE RELATED. THE PATIENT WAS ADMINISTERED WITH ANTIBIOTICS AND UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1669875 WAVEWRITER ALPHA? 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1216 784985 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention