BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA?

    MDR report key: 22730389 · Received August 6, 2025

    Report

    Report Number
    3006630150-2025-06194
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    July 9, 2025
    Report Date
    August 6, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, BASED OFF BSC AWARE DATE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: 7079962. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(6). BATCH: 7080272. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7087017. UDI: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7086987. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED BRUISING OVER THE THORACIC INSERTION SITE OF THE LEADS OF THE SPINAL CORD STIMULATOR (SCS) SYSTEM. IT WAS NOTED THAT THE PATIENT HAS NOT EXPERIENCED TRAUMA TO THE SITE THEREFORE THERE IS NO EXPLANATION AS TO THE CAUSE OF THE BRUISING. IT WAS ALSO NOTED THAT THE BRUISING IS TRACKING UP TOWARDS THE IMPLANTABLE PULSE GENERATOR (IPG) SITE, AND THERE IS CONCERN OF ADDITIONAL CONSEQUENCES TO THE PATIENT. THE PATIENT WAS GIVEN ANTIBIOTICS, ADMITTED TO THE HOSPITAL WHEREIN IMAGING WAS TAKEN, BLOOD TESTS WERE PERFORMED AND CULTURES WERE TAKEN. THE BLOOD TESTS DID NOT INDICATE ANY OBVIOUS ANOMALIES. ADDITIONALLY, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DURING WHICH THE SCS SYSTEM WAS REMOVED. THERE WERE NO REPORTED PATIENT COMPLICATIONS POST OPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1765359 WAVEWRITER ALPHA? STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1232 570163 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Hospitalization| R