BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 5771039 · Received July 5, 2016

    Report

    Report Number
    3006630150-2016-01755
    Event Type
    Injury
    Date Received
    July 5, 2016
    Date of Event
    May 26, 2016
    Report Date
    May 26, 2016
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-8120-70, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO FURTHER INFORMATION COULD BE OBTAINED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S DEVICES WILL BE REPLACED FOR AN UNKNOWN REASON.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S DEVICES WILL BE REPLACED FOR AN UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422552 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention