BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 10185868 · Received June 23, 2020

    Report

    Report Number
    3006630150-2020-02574
    Event Type
    Injury
    Date Received
    June 23, 2020
    Date of Event
    June 1, 2020
    Report Date
    June 30, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, A TECHNICAL PRODUCT ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING CRAMPING IN THE RIB AREA. THE PATIENT HAD THE DEVICE REMOVED. DURING THE REMOVAL, THE DOCTOR SAW THAT BONE STARTED TO GROW OVER THE LEAD AND THOUGHT THIS WAS WHAT CAUSED THE RIB CRAMPING. THE DATABASE WAS SENT IN AND THE ANALYSIS REVEALED THAT THE BATTERY DISCHARGE AND CHARGE PROFILES WERE OBSERVED AND REVEALED NO ANOMALIES. THE HISTORY COUNTERS SHOW A RESET VALUE WITHIN A NORMAL RANGE. THE IMPEDANCE MEASUREMENTS WERE OBSERVED TO BE WITHIN A NORMAL RANGE. THE IPG APPEARS TO BE WORKING AS EXPECTED. THE EXPLANTED DEVICES WILL BE RETURNED.

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS PADDLE LEADS, UPN: (B)(4), MODEL: SC 8216 50, SERIAL: (B)(4), BATCH: 7027075. 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: 7050102/ 7050121.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED RIB CRAMPING. THE PHYSICIAN EXPLANTED THE DEVICES AND NOTICED THAT A BONE STARTED TO GROW OVER THE LEAD AND BELIEVED IT CAUSED THE RIB CRAMPING. DATABASE ANALYSIS FOR IPG REVEALED NO ANOMALIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650974 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 349470 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention