BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA 16

    MDR report key: 16940255 · Received May 16, 2023

    Report

    Report Number
    3006630150-2023-02768
    Event Type
    Injury
    Date Received
    May 16, 2023
    Date of Event
    April 27, 2023
    Report Date
    May 16, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: 7121254/7121646.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING AN INFECTION. SYMPTOMS WERE SWELLING, REDNESS AND WARMTH TO TOUCH AT THE POCKET SITE. IT WAS ALSO NOTED THAT PATIENT WAS ALSO ITCHING AND SCRATCHED THE INCISION AREA. THE PHYSICIAN FLUSH OUT BOTH INCISIONS WITH ANTIBIOTICS AND EXPLANTED THE ENTIRE SPINAL CORD STIMULATOR (SCS) SYSTEM. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864541 WAVEWRITER ALPHA 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1216 557436 08714729985082

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention