BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 17762131 · Received September 16, 2023

    Report

    Report Number
    3006630150-2023-05605
    Event Type
    Injury
    Date Received
    September 16, 2023
    Date of Event
    August 24, 2023
    Report Date
    September 16, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8336700, MODEL: SC-8336-70, SERIAL: (B)(6), BATCH: 7072553.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS BLEEDING AT THE INCISION SITE AFTER THE SPINAL CORD STIMULATOR (SCS) SYSTEM WAS IMPLANTED. THE PATIENT WAS KEPT OVERNIGHT TO BE MONITORED AND THE ISSUE PERSISTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND THE BLEEDING HAD STOPPED. ALL DEVICE COMPONENTS WERE REMOVED AND DISCARDED. NO DEVICE MALFUNCTION SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779144 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 579381 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention| H