BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 18251055 · Received December 1, 2023

    Report

    Report Number
    3006630150-2023-07507
    Event Type
    Injury
    Date Received
    December 1, 2023
    Date of Event
    November 7, 2023
    Report Date
    April 3, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2352500; MODEL: SC-2352-50; SERIAL: (B)(6); BATCH: 7072836 / 7072854.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED INFECTION AT THE IPG SITE. SYMPTOMS OF REDNESS WAS NOTED. THE PATIENT WILL UNDERGO EXPLANT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED INFECTION AT THE IPG SITE. SYMPTOMS OF REDNESS WAS NOTED. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431033 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 560354 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention