BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 11757925 · Received April 30, 2021

    Report

    Report Number
    3006630150-2021-01880
    Event Type
    Injury
    Date Received
    April 30, 2021
    Date of Event
    April 8, 2021
    Report Date
    April 30, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8336500, MODEL: SC-8336-50, SERIAL: (B)(4), BATCH: 7073600.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE POCKET SITE. SYMPTOM OF DISCHARGE OOZING FROM THE POCKET SITE WAS NOTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICES WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647561 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 503681 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention