BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11391474 · Received March 1, 2021

    Report

    Report Number
    3006630150-2021-00673
    Event Type
    Injury
    Date Received
    March 1, 2021
    Date of Event
    February 2, 2021
    Report Date
    March 1, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURED SIX WEEKS AFTER IMPLANT FROM DATE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: (B)(4) MODEL: SC-8336-50 SERIAL: (B)(4). BATCH: 7072991

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING AN INFECTION AT THE INCISION SITES. SYMPTOMS OF DISCHARGE AND PAIN WERE NOTED. IT WAS ALSO NOTED THAT THE CAUSE OF THE INFECTION WAS UNKNOWN. THE PHYSCIAN BELIEVED THAT THE NON-DEVICE RELATED SURGERY CONTRIBUTED INFECTION. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292348 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 371162 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention