BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11442824 · Received March 9, 2021

    Report

    Report Number
    3006630150-2021-00830
    Event Type
    Injury
    Date Received
    March 9, 2021
    Date of Event
    January 25, 2021
    Report Date
    March 9, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8216700 MODEL: SC-8216-70 SERIAL: (B)(4). BATCH: 7070984.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT DUE TO INFECTION. IT WAS NOTED THAT THE IPG POCKET SITE WAS OOZING. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND WAS PLACED ON INTRAVENOUS ANTIBIOTICS. THE EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343226 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 374549 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention