BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 15979053 · Received December 14, 2022

    Report

    Report Number
    3006630150-2022-06994
    Event Type
    Injury
    Date Received
    December 14, 2022
    Date of Event
    June 16, 2020
    Report Date
    December 14, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE: EXACT DATE UNKNOWN, EVENT OCCURRED A YEAR PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(4); BATCH: 7072578/7072742.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IPG SITE WAS UNCOMFORTABLE. THE PATIENT ALSO NOTED THAT THE STIMULATION WAS CAUSING INCREASED PAIN AND DISCOMFORT. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND THE EXPLANTED DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141827 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 359838 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention