BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA PRIME

    MDR report key: 18000156 · Received October 24, 2023

    Report

    Report Number
    3006630150-2023-06510
    Event Type
    Injury
    Date Received
    October 24, 2023
    Date of Event
    October 3, 2023
    Report Date
    October 24, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6) , BATCH: 7132795/7132713.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS INCISION WAS NOT CLOSING PROPERLY DUE TO MANY SKIN GRAFTS FROM A HOUSEFIRE BURN. THE PHYSICIAN OPENED AND CLEANED THE IPG SITE, THEN CLOSED THE INCISION. THE PATIENT WAS PLACED ON ANTIBIOTICS. IT WAS NOTED THAT THE IPG SITE WAS STILL QUESTIONABLE, AND THE PHYSICIAN DECIDED TO EXPLANT THE ENTIRE SPINAL CORD STIMULATOR (SCS) SYSTEM. THE PATIENT WAS REPORTEDLY DOING WELL. THE EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847660 WAVEWRITER ALPHA PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1432 220336 08714729985075

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention