BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8648207 · Received May 28, 2019

    Report

    Report Number
    3006630150-2019-02510
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    May 7, 2019
    Report Date
    June 17, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS RESPONDING WELL TO THE ANTIBIOTICS GIVEN.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENTS INCISION SITES HAD A SUSPECTED INFECTION. SYMPTOMS OF RASH AND IRRITATION WERE NOTED. PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AS A RESULT, PATIENTS CERVICAL INCISION SITE WAS RESPONDING WELL. HOWEVER THE INCISION AT THE BATTERY SITE WAS STILL INFLAMED.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-8216-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7040399, MODEL/CATALOG DESCRIPTION: ARTISAN LEAD 50 CM, MODEL NUMBER/CATALOG NUMBER: SC-8216-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7040693, MODEL/CATALOG DESCRIPTION: ARTISAN LEAD 70 CM. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE DEVICES REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WAS FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENTS INCISION SITES HAD A SUSPECTED INFECTION. SYMPTOMS OF RASH AND IRRITATION WERE NOTED. PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AS A RESULT, PATIENTS CERVICAL INCISION SITE WAS RESPONDING WELL. HOWEVER THE INCISION AT THE BATTERY SITE WAS STILL INFLAMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441423 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 350386 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention