BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2852943 · Received November 30, 2012

    Report

    Report Number
    3006630150-2012-02210
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S NEW PAIN WAS NOT DEVICE RELATED. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE TREATMENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING NEW PAIN AROUND HIS IPG SITE WHETHER DEVICE WAS ON OR OFF. THE PATIENT WAS GIVEN STEROID INJECTION; HOWEVER, THE PATIENT WAS STILL EXPERIENCING PAIN AFTER THE INJECTIONS WERE PERFORMED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING NEW PAIN AROUND HIS IPG SITE WHETHER DEVICE WAS ON OR OFF. THE PATIENT WAS GIVEN STEROID INJECTION; HOWEVER, THE PATIENT WAS STILL EXPERIENCING PAIN AFTER THE INJECTIONS WERE PERFORMED.

    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 83 YR Other| R