BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 17733850 · Received September 12, 2023

    Report

    Report Number
    3006630150-2023-05503
    Event Type
    Injury
    Date Received
    September 12, 2023
    Date of Event
    February 14, 2023
    Report Date
    September 12, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6). BATCH: 7080852/7081289.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A BLOOD PATCH PROCEDURE DUE TO AN ONGOING HEADACHE. NO DEVICE MALFUNCTION WAS SUSPECTED. ALL COMPONENTS WERE EXPLANTED AND WILL NOT BE RETURNED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146153 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 560737 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention