BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 17885913 · Received October 6, 2023

    Report

    Report Number
    3006630150-2023-06078
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    March 18, 2023
    Report Date
    September 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED 3 MONTHS AGO FROM DATE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: (B)(4). MODEL: SC-2366-70. SERIAL: (B)(6). BATCH: 7073199/7072903.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG AND LEAD SITES. THE PATIENTS SYMPTOMS WERE REDNESS AND FLUID DISCHARGE. IT WAS ALSO NOTED THAT THE PATIENTS LEAD WAS COMING OUT OF THE SKIN. THE PHYSICIAN BELIEVED IT WAS DEVICE RELATED. THE PHYSICIAN CLIPPED THE DISTAL CONTACT OF THE LEAD AND SUTURED DOWN ALONG AND CLOSED THE WOUND. THE PATIENT WAS ON LONG TERM ANTIBIOTICS AND WAS DOING WELL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG AND LEAD SITES. THE PATIENTS SYMPTOMS WERE REDNESS AND FLUID DISCHARGE. IT WAS ALSO NOTED THAT THE PATIENTS LEAD WAS COMING OUT OF THE SKIN. THE PHYSICIAN BELIEVED IT WAS DEVICE RELATED. THE PHYSICIAN CLIPPED THE DISTAL CONTACT OF THE LEAD AND SUTURED DOWN ALONG AND CLOSED THE WOUND. THE PATIENT WAS ON LONG TERM ANTIBIOTICS AND WAS DOING WELL. ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT WAS STILL EXPERIENCING AN ONGOING INFECTION AND IT HAD WORSENED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342326 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 535725 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention