BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11274572 · Received February 3, 2021

    Report

    Report Number
    3006630150-2021-00219
    Event Type
    Injury
    Date Received
    February 3, 2021
    Date of Event
    January 11, 2021
    Report Date
    February 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2317-70, SERIAL: (B)(4), BATCH: 7073693/7073730.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG SITE POST IMPLANT PROCEDURE. SYMPTOMS OF ERYTHEMA, HEADACHE AND SKIN IRRITATION WERE NOTED. IT WAS UNKNOWN WHAT CAUSED OR CONTRIBUTED TO THE INFECTION. THE PATIENT HAD EXTENDED ANTIBIOTICS CONCERNING FOR POSTOPERATIVE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN EVERYTHING WAS REMOVED. THE EXPLANTED DEVICE COMPONENTS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170158 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 373676 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention