BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3223028 · Received July 12, 2013

    Report

    Report Number
    3006630150-2013-01438
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    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

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING WARMTH AT THE POCKET SITE WHEN CHARGING. THE PAIN WAS BELIEVED TO BE DUE TO THE ADHESIVE PATCHES USED WHILE CHARGING. THE PATIENT WAS GIVEN A LIDODERM PATCH ON THE SITE. NO FURTHER COURSE OF ACTION WILL BE TAKEN. THERE WILL BE NO FURTHER INFORMATION PROVIDED TO BSN REGARDING PATIENT'S MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322577 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention