BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 14573558 · Received June 2, 2022

    Report

    Report Number
    3006630150-2022-02645
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    April 22, 2022
    Report Date
    December 8, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7101113/7101216.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG SITE WITH SYMPTOMS OF DRAINAGE AND A SMALL ULCERATION WHICH LIKELY CAUSED BY LOCALIZED RUBBING IN THE AREA LEADING TO A SEROMA. THE IPG STARTED TO COME THROUGH THE SKIN AND WAS EXPOSED. IT WAS NOTED THAT THE IPG WAS TILTING IN THE POCKET SITE SINCE IMPLANT. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE EXPLANTED. ALL EXPLANTED DEVICES WAS KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG SITE WITH SYMPTOMS OF DRAINAGE AND A SMALL ULCERATION WHICH LIKELY CAUSED BY LOCALIZED RUBBING IN THE AREA LEADING TO A SEROMA. THE IPG STARTED TO COME THROUGH THE SKIN AND WAS EXPOSED. IT WAS NOTED THAT THE IPG WAS TILTING IN THE POCKET SITE SINCE IMPLANT. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE EXPLANTED. ALL EXPLANTED DEVICES WAS KEPT BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS HAVING PAIN AT THE IPG SITE SINCE THE IMPLANTATION AND BECAME EXPOSED OVER TIME. THE PHYSICIAN BELIEVED IT WAS NOT INFECTED AND THE CAUSE OF THE SYMPTOMS WERE UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG SITE WITH SYMPTOMS OF DRAINAGE AND A SMALL ULCERATION WHICH LIKELY CAUSED BY LOCALIZED RUBBING IN THE AREA LEADING TO A SEROMA. THE IPG STARTED TO COME THROUGH THE SKIN AND WAS EXPOSED. IT WAS NOTED THAT THE IPG WAS TILTING IN THE POCKET SITE SINCE IMPLANT. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE EXPLANTED. ALL EXPLANTED DEVICES WERE KEPT BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS HAVING PAIN AT THE IPG SITE SINCE THE IMPLANTATION AND BECAME EXPOSED OVER TIME. THE PHYSICIAN BELIEVED IT WAS NOT INFECTED AND THE CAUSE OF THE SYMPTOMS WERE UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENTS ISSUES WERE NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184968 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 529298 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention