BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 12965429 · Received December 8, 2021

    Report

    Report Number
    3006630150-2021-07056
    Event Type
    Injury
    Date Received
    December 8, 2021
    Date of Event
    January 22, 2021
    Report Date
    December 8, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED THREE MONTHS AGO. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7083125/7083731. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7075283/7075289.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING MORE PAIN WHEN USING THE DEVICE, ESPECIALLY UNDER THE SHOULDER BLADE. THE PATIENT HAD MULTIPLE REPROGRAMMING'S BUT WAS STILL HAVING PAIN. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE ADJUSTED TO COVER THE PAIN AREA AND THE IPG WAS REPLACED WITH AN MRI COMPATIBLE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858225 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 374232 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Required Intervention