BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3083601 · Received April 29, 2013

    Report

    Report Number
    3006630150-2013-00898
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT¿S PAIN WAS A NEW PAIN. THE PHYSICIAN BELIEVED THAT THE NEW PAIN WAS NOT DEVICE OR PROCEDURE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT RECEIVED A STEROID INJECTION AT THE SACROILIAC JOINT DUE TO PAIN. IT WAS UNKNOWN IF THE PAIN WAS PROCEDURE OR DEVICE RELATED. THE PATIENT ACHIEVED RELIEF.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT RECEIVED A STEROID INJECTION AT THE SACROILIAC JOINT DUE TO PAIN. IT WAS UNKNOWN IF THE PAIN WAS PROCEDURE OR DEVICE RELATED. THE PATIENT ACHIEVED RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185246 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention