BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11987312 · Received June 11, 2021

    Report

    Report Number
    3006630150-2021-02877
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    December 1, 2020
    Report Date
    July 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE. SYMPTOMS OF SWOLLEN AND PURULENT DRAINAGE WERE NOTED ON THE SITE. THE PATIENT WAS PLACED ON ANTIBIOTICS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CAUSE OF INFECTION WAS UNKNOWN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND THE EXPLANTED DEVICES WERE NOT RETURNED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7081845 / 7081960.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE. SYMPTOMS OF SWOLLEN AND PURULENT DRAINAGE WERE NOTED ON THE SITE. THE PATIENT WAS PLACED ON ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878434 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 372074 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention