BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 11195527 · Received January 19, 2021

    Report

    Report Number
    3006630150-2020-06703
    Event Type
    Injury
    Date Received
    January 19, 2021
    Date of Event
    December 9, 2020
    Report Date
    January 19, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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-2218-50, SERIAL: (B)(4), BATCH: 7081363/ 7081397.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IPG DUE TO THE SWELLING, SKIN IRRITATION AND REDNESS AT THE IPG AND LEAD INCISION SITES. A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS TAKEN AND REVEALED THAT THE PATIENT WAS DIAGNOSED WITH CELLULITIS. IT WAS ALSO REPORTED THAT THE PATIENT HAD BLISTERS AND TOPICAL DERMATITIS FROM THE BANDAGE AT THE LEAD INCISION SITE. THE PATIENT WAS SENT TO THE EMERGENCY ROOM AND THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS, VALIUM AND ANTARAX. ALL DEVICE COMPONENTS WERE EXPLANTED AND WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93513 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 372025 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention