BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 14120326 · Received April 15, 2022

    Report

    Report Number
    3006630150-2022-01668
    Event Type
    Injury
    Date Received
    April 15, 2022
    Date of Event
    March 24, 2022
    Report Date
    May 9, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE: EXACT DATE UNKNOWN, EVENT OCCURRED APPROXIMATELY ON (B)(6) 2022.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7070842/7082825.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING FATIGUE AND WEAKNESS DUE TO (B)(6) INFECTION AT THE IPG SITE. THE PATIENT UNDERWENT AN IPG EXPLANT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING FATIGUE AND WEAKNESS DUE TO STAPHYLOCOCCUS INFECTION AT THE IPG SITE. THE PATIENT UNDERWENT AN IPG EXPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT STATED THAT SHE WAS PRONE TO INFECTIONS. THE SPINAL CORD STIMULATOR (SCS) SYSTEM WAS EXPLANTED. THE EXPLANTED IPG AND LEADS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907693 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 528139 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention