BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 15740374 · Received November 4, 2022

    Report

    Report Number
    3006630150-2022-06001
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    September 26, 2022
    Report Date
    November 4, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(4). BATCH: 7113045/7113084.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IPG POCKET WAS SWOLLEN AND STILL DRAINING DESPITE THE PRESCRIBED ANTIBIOTICS. IT WAS ALSO NOTED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING THE IPG. THE PATIENT WAS SUPPOSED TO BE REVISED, HOWEVER PATIENTS PHYSICAL EXAM SHOWED THAT THE MIDLINE SPINAL INCISION HAD DEHISCED AND APPEARED TO BE ACTIVELY INFECTED. THE PHYSICIAN OPTED TO EXPLANT ALL DEVICE COMPONENTS. THE EXPLANTED IPG AND LEADS WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2529274 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 548352 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention