BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 17500235 · Received August 10, 2023

    Report

    Report Number
    3006630150-2023-04690
    Event Type
    Injury
    Date Received
    August 10, 2023
    Date of Event
    July 20, 2023
    Report Date
    August 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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)(6), BATCH: 7091887. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317700, MODEL: SC-2317-70, SERIAL: (B)(6), BATCH: 7082574.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER BEING IMPLANTED PATIENT WAS EXPERIENCING SEVERE ABDOMINAL PAIN, ABDOMINAL SPASM AND DISTENSION. THE PHYSICIAN NOTED THAT THE PATIENTS BOWEL SHUT DOWN. REPROGRAMMING WAS DONE HOWEVER THE STIMULATION AGGRAVATED THE PATIENTS EXISTING PAIN AND SPASM. THE PATIENT WAS TREATED WITH MEDICATION AND WAS DOING MUCH BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949833 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 568001 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention