BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 13148982 · Received January 4, 2022

    Report

    Report Number
    3006630150-2021-07442
    Event Type
    Injury
    Date Received
    January 4, 2022
    Date of Event
    October 25, 2021
    Report Date
    February 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
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED A WEEK AFTER IMPLANT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(4), BATCH: 7070617 / 7073268.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A WEEK FOLLOWING IMPLANT, THE PATIENT DEVELOPED AN INFECTION ACROSS BOTH IPG AND LEAD INCISION SITES. SYMPTOMS OF REDNESS, WARM TO TOUCH AND SORENESS WERE NOTED. THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED AND THE CAUSE WAS UNKNOWN. THE PATIENT WAS PRESCRIBED ANTIBIOTICS, TREATED AND CLEARED OF INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A WEEK FOLLOWING IMPLANT, THE PATIENT DEVELOPED AN INFECTION ACROSS BOTH IPG AND LEAD INCISION SITES. SYMPTOMS OF REDNESS, WARM TO TOUCH AND SORENESS WERE NOTED. THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED AND THE CAUSE WAS UNKNOWN. THE PATIENT WAS PRESCRIBED ANTIBIOTICS, TREATED AND CLEARED OF INFECTION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE NOT RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706725 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 522991 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention