BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11881049 · Received May 25, 2021

    Report

    Report Number
    3006630150-2021-02381
    Event Type
    Injury
    Date Received
    May 25, 2021
    Date of Event
    October 11, 2020
    Report Date
    May 25, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2020. EXPLANT DATE: (B)(6) 2020. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7070582 / 7077942.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED AN INFECTION AT THE POCKET SITE. SYMPTOMS OF INFECTION WERE REDNESS AND SWELLING. THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT A SPINAL CORD STIMULATOR SYSTEM EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772739 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 368290 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention