BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 19358354 · Received May 21, 2024

    Report

    Report Number
    3006630150-2024-03270
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    April 2, 2024
    Report Date
    May 21, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: 7123257/7124797.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING AN IPG REPLACEMENT PROCEDURE, THE PATIENT DEVELOPED AN INFECTION AT THE IPG SITE. SYMPTOM OF SORENESS WAS NOTED. IT WAS UNKNOWN WHAT CAUSED THE INFECTION. THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT AND ALL COMPONENTS WERE EXPLANTED AND DISCARDED PER HOSPITAL POLICY. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603654 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 599929 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Hospitalization| R