BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2880090 · Received December 19, 2012

    Report

    Report Number
    3006630150-2012-02367
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 29, 2012
    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 COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-4316, LOT #:15495824, DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE; MODEL #: SC-8216-70, SERIAL #: (B)(4), DESCRIPTION:ARTISAN SURGICAL LEAD, 70CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS IN COMA POST-OPERATIVELY WHEREIN, A FUSION WAS PERFORMED AT THE SAME TIME STIMULATOR WAS PUT IN. THE PHYSICIAN BELIEVED THE COMA WAS NON DEVICE RELATED. THE PATIENT HAD EXISTING HEALTH CONDITIONS AND TREATMENT WAS PROVIDED. THE PATIENT WAS FIT TO BE SENT HOME AND WAS DOING BETTER.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS IN COMA ON THE DATE OF THE IMPLANT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS IN COMA ON THE DATE OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other