BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 12944495 · Received December 6, 2021

    Report

    Report Number
    3006630150-2021-06977
    Event Type
    Injury
    Date Received
    December 6, 2021
    Date of Event
    November 16, 2021
    Report Date
    December 6, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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-PADDLE LEADS, UPN: M365SC8336700, MODEL: SC-8336-70, SERIAL: (B)(4), BATCH: 7071648. PRODUCT FAMILY: SCS-LEAD FIXATION, UPN: M365SC43180, MODEL: SC-4318, BATCH: 28093987.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. SYMPTOM OF INFECTION WAS INFLAMMATION THAT WAS NOTICED AT THE POCKET SITE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT PROCEDURE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS PLACED ON ANTIBIOTICS. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WERE NOT RETURNED TO BSN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1841574 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 516508 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention