BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 5746984 · Received June 23, 2016

    Report

    Report Number
    3006630150-2016-01626
    Event Type
    Injury
    Date Received
    June 23, 2016
    Date of Event
    May 27, 2016
    Report Date
    May 27, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-8216-50, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS CONFIRMED TO HAVE AN INFECTION. THE INFECTION WAS NOT RELATED TO THE DEVICE OR PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-8216-50 SERIAL #: (B)(4) DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING IRRITATION AND REDNESS AT BOTH INCISION SITES. THE PHYSICIAN PRESCRIBED ANTIBIOTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING IRRITATION AND REDNESS AT THE IPG SITE. THE PHYSICIAN PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400422 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention