BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION SPECTRA

    MDR report key: 7351703 · Received March 19, 2018

    Report

    Report Number
    3006630150-2018-01010
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    February 28, 2018
    Report Date
    March 19, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    030017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8216-50 SERIAL #: (B)(4) DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM MODEL #: SC-8216-70 SERIAL #: (B)(4) DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PHYSICIAN USED ELECTROCAUTERY AND FRIED THE LEAD DURING FUSION SURGERY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD AND IPG WERE REPLACED DUE TO DIRECT ELECTROCAUTERY ON THE LEAD. NO DEVICE MALFUNCTION WAS SUSPECTED. ELECTROCAUTERY IS A KNOWN SOURCE OF HIGH VOLTAGE TRANSIENT SIGNAL AND CURRENT COMPANY LABELING WARNS AGAINST THE USE OF ELECTROCAUTERY. (PHYSICIAN¿S IMPLANT MANUAL (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193282 PRECISION SPECTRA SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR