BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 15940865 · Received December 8, 2022

    Report

    Report Number
    3006630150-2022-06792
    Event Type
    Injury
    Date Received
    December 8, 2022
    Date of Event
    November 12, 2022
    Report Date
    December 30, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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)(4), BATCH: 7102189 / 7102420.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE. SYMPTOMS OF PAIN, TENDERNESS, SWELLING AND TWO SUPERFICIAL PUSTULES AT THE SITE WERE NOTED. THE CAUSE OF INFECTION WAS UNKNOWN. THE PHYSICIAN SUSPECTED THAT THE PATIENT COULD BE ALLERGIC TO THE MATERIALS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE. SYMPTOMS OF PAIN, TENDERNESS, SWELLING AND TWO SUPERFICIAL PUSTULES AT THE SITE WERE NOTED. THE CAUSE OF INFECTION WAS UNKNOWN. THE PHYSICIAN SUSPECTED THAT THE PATIENT COULD BE ALLERGIC TO THE MATERIALS. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2260035 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 544767 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention