BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 18205659 · Received November 24, 2023

    Report

    Report Number
    3006630150-2023-07353
    Event Type
    Injury
    Date Received
    November 24, 2023
    Date of Event
    October 27, 2023
    Report Date
    January 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR FIXATION, UPN: M365SCSC43160, MODEL: SC-4316, BATCH: (B)(6).

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED A MONTH AFTER THE IMPLANT PROCEDURE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(6); BATCH: 7128662/7131585.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION ON BOTH IPG AND LEAD INCISION FOLLOWING AN IMPLANT PROCEDURE. SIGNS AND SYMPTOMS OF SORENESS AND REDNESS WERE NOTED AT THE ANCHOR SITE. THE PHYSICIAN WAS UNSURE AND DOES NOT KNOW IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT WAS DOING WELL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG SITE WAS IRRIGATED AND THE LEAD AND ANCHOR WERE EXPLANTED. THE PATIENT WAS PLACED ON INTRAVENOUS (IV) ANTIBIOTICS. THE EXPLANTED DEVICES WERE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION ON BOTH IPG AND LEAD INCISION FOLLOWING AN IMPLANT PROCEDURE. SIGNS AND SYMPTOMS OF SORENESS AND REDNESS WERE NOTED AT THE ANCHOR SITE. THE PHYSICIAN WAS UNSURE AND DOES NOT KNOW IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT WAS DOING WELL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION ON BOTH IPG AND LEAD INCISION SITES FOLLOWING THE IMPLANT PROCEDURE. SIGNS AND SYMPTOMS OF SORENESS AND REDNESS WERE NOTED AT THE ANCHOR SITE. THE PHYSICIAN WAS UNSURE AND DOES NOT KNOW IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219974 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 584155 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention