BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 12351236 · Received August 20, 2021

    Report

    Report Number
    3006630150-2021-04658
    Event Type
    Injury
    Date Received
    August 20, 2021
    Date of Event
    July 26, 2021
    Report Date
    August 20, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: 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: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 7073291 / 7073346.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A FEELING OF BEES STINGING AT THE IPG SITE EVEN WHEN STIMULATION WAS TURNED OFF. IT WAS ALSO REPORTED THAT THE PATIENT HAD SHOCKING PAIN AT THE LEAD SITE EVERY TIME IT WAS PRESSED. IT WAS NOTED THAT THE PATIENT FELL ON THE SIDE WHERE THE IPG WAS LOCATED AND WAS BRUISED UP. THE PHYSICIAN INJECTED LIDOCAINE AND STEROID TO THE AREA AND THE SYMPTOMS HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245638 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 509835 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention