BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11363020 · Received February 22, 2021

    Report

    Report Number
    3006630150-2021-00590
    Event Type
    Injury
    Date Received
    February 22, 2021
    Date of Event
    February 2, 2021
    Report Date
    February 22, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 5143709/7071127. PRODUCT FAMILY: SCS-LEAD FIXATION: UPN: (B)(4), MODEL: SC-4318, BATCH: 24107724.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS IPG POCKET INCISION SITE OPENED AND WAS BLEEDING MAKING THE IPG VISIBLE. THE PATIENT WENT TO THE EMERGENCY ROOM AND UNDERWENT A SPINAL CORD STIMULATOR (SCS) SYSTEM EXPLANT PROCEDURE. THE PATIENTS WOUND WAS PACKED WITH VANCOMYCIN PELLETS AND NO COMPLICATIONS WERE NOTED. NO DEVICE MALFUNCTION WAS SUSPECTED. THE EXPLANTED DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259255 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 375057 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention