BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 15085035 · Received July 22, 2022

    Report

    Report Number
    3006630150-2022-03620
    Event Type
    Injury
    Date Received
    July 22, 2022
    Date of Event
    June 29, 2022
    Report Date
    July 22, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2022. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 5042285/5030630.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FAT TISSUE NECROSIS WAS NOTED AT THE PATIENT IPG SITE. THE PHYSICIAN BELIEVED THAT NECROSIS WAS NOT DEVICE RELATED. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116297 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 335912 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention