BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11282989 · Received February 4, 2021

    Report

    Report Number
    3006630150-2021-00289
    Event Type
    Injury
    Date Received
    February 4, 2021
    Date of Event
    November 6, 2020
    Report Date
    March 10, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7071869/7071929.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE JOINTS. THERE WAS AN EPISODE WHEREIN THE PATIENT EXPERIENCED THE PAIN IN THE KNEE WHEREIN THE PATIENT WAS NOT ABLE TO STRAIGHTEN IT. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED SKIN BURNING AS WELL AS SORE FEELING IN THE HEAD AND INADEQUATE STIMULATION. THE PATIENT WAS PRESCRIBED WITH MOBIC. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS KNEE PAIN WAS NOT DEVICE RELATED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE EXPLANTED DEVICES WERE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURRED TWO MONTHS AGO FROM THE DATE THE MANUFACTURER WAS MADE AWARE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE JOINTS. THERE WAS AN EPISODE WHEREIN THE PATIENT EXPERIENCED THE PAIN IN THE KNEE WHEREIN THE PATIENT WAS NOT ABLE TO STRAIGHTEN IT. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED SKIN BURNING AS WELL AS SORE FEELING IN THE HEAD AND INADEQUATE STIMULATION. THE PATIENT WAS PRESCRIBED WITH MOBIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177304 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 353475 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention