BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3841918 · Received May 30, 2014

    Report

    Report Number
    3006630150-2014-01245
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    February 12, 2014
    Report Date
    April 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-8216-70 SERIAL/LOT (B)(4) DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING BURNING SENSATION, DISCOMFORT AND PAIN AT BOTH INCISION SITES. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PHYSICIAN DID NOT SUSPECT MALFUNCTION BUT BELIEVED THAT THE PATIENT¿S BODY WAS NOT RESPONDING WELL TO HAVING AN IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319225 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention