BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 11334839 · Received February 16, 2021

    Report

    Report Number
    3006630150-2021-00499
    Event Type
    Injury
    Date Received
    February 16, 2021
    Date of Event
    February 2, 2021
    Report Date
    March 25, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO INITIAL MDR IN BLOCK H6.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING AN INFECTION WITH SYMPTOMS OF PAIN AND FEVER. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS ADMINISTERED ANTIBIOTICS.THE PATIENT IS DOING WELL POST-OPERATIVELY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 7073703. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 7073239.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING AN INFECTION WITH SYMPTOMS OF PAIN AND FEVER. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS ADMINISTERED ANTIBIOTICS. THE PATIENT IS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229294 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 501559 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention