BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRA WAVEWRITER

    MDR report key: 8578563 · Received May 3, 2019

    Report

    Report Number
    3006630150-2019-02035
    Event Type
    Injury
    Date Received
    May 3, 2019
    Date of Event
    April 15, 2019
    Report Date
    May 24, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729951254
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL NUMBER/CATALOG NUMBER: SC-2218-70 SERIAL NUMBER: (B)(4) BATCH/LOT NUMBER: 5109977/5110862 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTION SITE WAS CENTRAL IN THE SPINE AT THE INCISION WHERE THE LEADS WERE PLACED AND NOT AT THE IPG SITE. 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 · 0

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING OOZING, LEAKING THAT WAS BROWN AND CONTAINED BLOOD. THE AREA WAS SWOLLEN AND VERY SENSITIVE TO TOUCH. THE WOUND CHECK SHOWED THAT THE PATIENT HAD DEVELOPED BACTERIAL INFECTION. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICE WAS FOUND TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING OOZING, LEAKING THAT WAS BROWN AND CONTAINED BLOOD. THE AREA WAS SWOLLEN AND VERY SENSITIVE TO TOUCH. THE WOUND CHECK SHOWED THAT THE PATIENT HAD DEVELOPED BACTERIAL INFECTION. THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370257 SPECTRA WAVEWRITER STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1160 344233 08714729951254

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention