BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 9756946 · Received February 26, 2020

    Report

    Report Number
    3006630150-2020-00808
    Event Type
    Injury
    Date Received
    February 26, 2020
    Date of Event
    February 6, 2020
    Report Date
    February 26, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: MODEL NUMBER/CATALOG NUMBER: SC-2218-50; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 7072055/7072721; MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG AND LEAD SITE. SYMPTOMS OF REDNESS AND LEAD COMING OUT FROM THE INCISION SITE WERE NOTED. THE PHYSICIAN BELIEVED IT COULD BE FROM THE PREVIOUS REVISION. THE PATIENT WAS PLACED ON ANTIBIOTICS AND WAS EXPLANTED. THE PATIENT WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221496 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 363924 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention