BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 16131032 · Received January 10, 2023

    Report

    Report Number
    3006630150-2022-07596
    Event Type
    Injury
    Date Received
    January 10, 2023
    Date of Event
    October 31, 2022
    Report Date
    January 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7076736/7080006/7080026/7080045.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HEADACHES WHEN USING THE SPINAL CORD STIMULATOR (SCS) DEVICE. IT WAS BELIEVED THAT THE PATIENT WAS GETTING OVERSTIMULATED AND MULTIPLE REPROGRAMMING SESSIONS WERE DONE, HOWEVER, THEY WERE UNSUCCESSFUL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE OLD LINEAR LEADS WERE DISCONNECTED FROM THE IPG, AND NEW LINEAR LEADS WERE IMPLANTED AND CONNECTED TO THE IPG. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE OLD LINEAR LEADS WERE ABANDONED AND REMAINED IN THE PATIENTS BODY. NOTHING WAS EXPLANTED AND NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195115 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 516274 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention