BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 18502813 · Received January 12, 2024

    Report

    Report Number
    3006630150-2023-08561
    Event Type
    Injury
    Date Received
    January 12, 2024
    Date of Event
    December 11, 2023
    Report Date
    July 3, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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: M365SC2317700.MODEL: SC-2317-70.SERIAL: (B)(6).LOT: 7082737.PRODUCT FAMILY: SCS-LINEAR LEADS.UPN: M365SC2317700.MODEL: SC-2317-70.SERIAL: (B)(6).LOT: 7082902.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). LOT: 7082737 . PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2317700. MODEL: SC-2317-70. SERIAL: (B)(6). LOT: 7082902.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT EXPERIENCED INCREASED SENSITIVITY AT THE SPINAL CORD STIMULATOR IMPLANTABLE PULSE GENERATOR (IPG) SITE AND RIB CAGE WITH MILD ERYTHEMA. THE PATIENT WAS ADMINISTERED OXYCODONE, ACETAMINOPHEN, AND ANTIBIOTICS. THE PATIENT HAD DEVELOPED AN INFECTION AT THE IPG AND LEAD SITES AND WAS ADMINISTERED TOPICAL ANTIBIOTICS AND REFERRED TO WOUND CARE. A SECOND WOUND CARE VISIT RESULTED IN REMOVAL OF A STITCH AND DEBRIDEMENT WITH A CURETTE. THE PATIENT WAS HEALING WELL, AND THE EVENT HAS RESOLVED. ALL DEVICES REMAIN IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CLINICAL STUDY PATIENT EXPERIENCED INCREASED SENSITIVITY AT THE SPINAL CORD STIMULATOR IMPLANTABLE PULSE GENERATOR (IPG) SITE AND RIB CAGE WITH MILD ERYTHEMA. THE PATIENT WAS ADMINISTERED OXYCODONE, ACETAMINOPHEN, AND ANTIBIOTICS. THE PATIENT HAD DEVELOPED AN INFECTION AT THE IPG AND LEAD SITES AND WAS ADMINISTERED TOPICAL ANTIBIOTICS AND REFERRED TO WOUND CARE. A SECOND WOUND CARE VISIT RESULTED IN REMOVAL OF A STITCH AND DEBRIDEMENT WITH A CURETTE. THE PATIENT WAS HEALING WELL, AND THE EVENT HAS RESOLVED. ALL DEVICES REMAIN IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED THAT SURGICAL DEHISCENCE WAS NOTED. THE TOPICAL ANTIBIOTICS WERE ADMINISTERED FOR STAPHYLOCOCCUS AUREUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1706106 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 568718 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention