BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2863167 · Received December 10, 2012

    Report

    Report Number
    3006630150-2012-02286
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL NOT UNDERGO AN EXPLANT PROCEDURE AS OF THIS TIME DUE TO NON-DEVICE RELATED MEDICAL ISSUES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING IRRITATION AND DISCOMFORT AT THE POCKET SITE. THE PHYSICIAN WILL EXPLANT THE PATIENT'S IPG.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING IRRITATION AND DISCOMFORT AT THE POCKET SITE. THE PHYSICIAN WILL EXPLANT THE PATIENT'S IPG.

    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 48 YR Required Intervention