BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3013694 · Received March 20, 2013

    Report

    Report Number
    3006630150-2013-00386
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AROUND THE AREA WHERE THE PADDLES ARE LOCATED ESPECIALLY WHEN THE STIMULATOR WAS TURNED ON. THE PHYSICIAN BELIEVED IT WAS PROCEDURE RELATED. THE PATIENT WAS GIVEN LIDODERM PATCHES FOR LEAD SITE PAIN. THE PATIENT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115955 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention