BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVEWRITER ALPHA

    MDR report key: 18554111 · Received January 22, 2024

    Report

    Report Number
    3006630150-2024-00167
    Event Type
    Injury
    Date Received
    January 22, 2024
    Date of Event
    December 23, 2023
    Report Date
    January 22, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729985099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: INFINION CX UPN: M365SC2317700 MODEL: SC-2317-70..\ SERIAL: (B)(6). BATCH: 5060630. BRAND NAME: INFINION CX UPN: M365SC2317700 MODEL: SC-2317-70 SERIAL: (B)(6). BATCH: 5139047.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION (SCS) IMPLANTABLE PULSE GENERATOR (IPG) WOUND HAD OPENED, AND THE PATIENT FELT UNWELL. THE PATIENT PRESENTED TO THE HOSPITAL AND THE PHYSICIAN GLUED IT BACK TOGETHER. A FEW DAYS LATER THE PATIENT EXPERIENCED REDNESS AROUND THE IPG SITE, AND A LINE OF REDNESS RAN UP HER BACK ALONG THE LOCATION OF THE SCS LEADS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND ADMINISTERED INTRAVENOUS (IV) CEPHAZOLIN. THE PHYSICIAN ASSESSED THAT SHE HAD A SEVERELY INFECTED SEROMA WITH TRAVELLING CELLULITIS, AND THE FOLLOWING DAY THE ENTIRE SYSTEM WAS EXPLANTED. A CULTURE WAS TAKEN WHICH CONFIRMED STAPHYLOCOCCUS LUGDUNENSIS. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND THE INFECTION IS RESOLVING. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1580011 WAVEWRITER ALPHA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1232 584451 08714729985099

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H