BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11841318 · Received May 18, 2021

    Report

    Report Number
    3006630150-2021-02187
    Event Type
    Injury
    Date Received
    May 18, 2021
    Date of Event
    February 24, 2021
    Report Date
    May 18, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURED THE DAY OF EXPLANT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2317500, MODEL: SC-2317-50, SERIAL: (B)(4), BATCH: 7070032/7071990.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SUSPECTED FOR INFECTION NEAR THE IPG AND LEAD SITE. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE. THE PHYSICIAN BELIEVED THE INFECTION WAS NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737706 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 370031 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention