BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3191341 · Received June 26, 2013

    Report

    Report Number
    3006630150-2013-01344
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 9, 2013
    Report Date
    June 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S SYMPTOMS HAVE NOW RESOLVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS ALSO EXPERIENCING SWELLING AT THE LEAD SITE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PROCEDURAL RELATED PAIN AT LEAD SITE IN THE NECK AREA. A TUMOR WAS NOTED AT THE SITE AS WELL. THE PATIENT'S MEDICATION WAS CHANGED AND THE EVENT HAS NOT RESOLVED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PROCEDURAL RELATED PAIN AT LEAD SITE IN THE NECK AREA. A TUMOR WAS NOTED AT THE SITE AS WELL. THE PATIENT'S MEDICATION WAS CHANGED AND THE EVENT HAS NOT RESOLVED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PROCEDURAL RELATED PAIN AT LEAD SITE IN THE NECK AREA. A TUMOR WAS NOTED AT THE SITE AS WELL. THE PATIENT'S MEDICATION WAS CHANGED AND THE EVENT HAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290877 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention