BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 7268777 · Received February 13, 2018

    Report

    Report Number
    3006630150-2018-00666
    Event Type
    Injury
    Date Received
    February 13, 2018
    Date of Event
    February 6, 2018
    Report Date
    February 13, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729779919
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-4319, LOT #: 21163822 DESCRIPTION: CLIK X MRI ANCHOR. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE ARTISAN LEAD AND CLIK ANCHOR 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 PATIENT HAD DEVELOPED AN INFECTION AT THE LEAD SITE. SYMPTOM OF PUS WAS NOTED. THE PHYSICIAN BELIEVED IT WAS NOT DEVICE RELATED, BUT THE CERVICAL INCISION DID NOT HEAL PROPERLY. ANTIBIOTICS WERE PRESCRIBED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE ARTISAN LEAD AND CLIK ANCHOR WERE EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110188 PRECISION SPECTRA SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 NA 08714729779919

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention