BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 4765567 · Received May 12, 2015

    Report

    Report Number
    3006630150-2015-00978
    Event Type
    Injury
    Date Received
    May 12, 2015
    Date of Event
    March 13, 2015
    Report Date
    March 13, 2015
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-8216-50, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM. THE EXPLANTED LEAD WAS NOT RETURNED TO BSN AS IT WAS KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING THE PATIENT'S PERMANENT IMPLANT, THE PHYSICIAN NICKED THE DURA IN TWO PLACES AFTER MULTIPLE ATTEMPTS OF PLACING THE LEAD. THE PHYSICIAN DECIDED TO SUTURE THE DURA AND PLACED A DURA PASTE TO CLOSE IT. THE PATIENT WAS ADMITTED IN THE HOSPITAL. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING A HEADACHE DUE TO A DURA LEAK AND A BLOOD PATCH WAS USED. THE BLOOD PATCH WAS NOT ABLE TO HELP WITH THE PATIENT'S HEADACHE THEREFORE THE PHYSICIAN PRESCRIBED MEDICATION. THE PATIENT¿S ISSUES HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309344 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R