BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 15135646 · Received July 29, 2022

    Report

    Report Number
    3006630150-2022-03757
    Event Type
    Injury
    Date Received
    July 29, 2022
    Date of Event
    June 17, 2022
    Report Date
    November 11, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7101522/7101536.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING AN IMPLANT PROCEDURE THE PATIENT EXPERIENCED INFECTION AT THE INCISION SITE. SYMPTOMS OF REDNESS, DRAINAGE FROM THE INCISION SITE AND FEVER WERE NOTED. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE RELATED. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING AN IMPLANT PROCEDURE THE PATIENT EXPERIENCED INFECTION AT THE INCISION SITE. SYMPTOMS OF REDNESS, DRAINAGE FROM THE INCISION SITE AND FEVER WERE NOTED. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE RELATED. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AND WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING AN IMPLANT PROCEDURE THE PATIENT EXPERIENCED INFECTION AT THE INCISION SITE. SYMPTOMS OF REDNESS, DRAINAGE FROM THE INCISION SITE AND FEVER WERE NOTED. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE RELATED. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AND WAS DOING WELL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430479 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 534724 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention