BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 19561379 · Received June 18, 2024

    Report

    Report Number
    3006630150-2024-03932
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    May 30, 2024
    Report Date
    June 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7137978/7133238. PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180. MODEL: SC-4318. BATCH: 31800392.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS HAD AN ONGOING WOUND ISSUE SINCE THE IMPLANT PROCEDURE, AND THE PATIENT KEPT PICKING THE INCISION SITE, WHICH PREVENTED IT FROM HEALING TO THE POINT WHERE AN INFECTION DEVELOPED. SYMPTOMS OF SORENESS AT THE INCISION SITE AND CLICK ANCHOR WERE NOTED. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS DUE TO IMPROPER WOUND CARE BY THE PATIENT. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND UNDERWENT A SYSTEM EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766152 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 594891 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention