BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 20076848 · Received August 27, 2024

    Report

    Report Number
    3006630150-2024-05643
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    July 27, 2024
    Report Date
    August 27, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED FIVE DAYS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6) /(B)(6) /(B)(6) /(B)(6). BATCH: 240791/241380/229883/A46875.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS WOUND AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE HAD OPENED UP AND THE IPG WAS VISIBLE IN THE POCKET. IT WAS NOTED THAT IT STARTED WITH A SMALL OPENING WITH FLUID DISCHARGE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICES WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29081 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 575414 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention