BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10943128 · Received December 3, 2020

    Report

    Report Number
    3006630150-2020-05995
    Event Type
    Injury
    Date Received
    December 3, 2020
    Date of Event
    November 12, 2020
    Report Date
    December 3, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7071972. APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE. SYMPTOMS OF SWELLING AND FLUID DISCHARGE WERE NOTED. THE PATIENT UNDERWENT A SPINAL CORD STIMULATOR EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE PATIENT WAS GIVEN ANTIBIOTICS. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS IT WAS KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406231 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 362663 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention