BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2870368 · Received December 12, 2012

    Report

    Report Number
    3006630150-2012-02304
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 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

    IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S INFECTION WAS GETTING BETTER AND HEALING WITH THE ANTIBIOTICS. INFECTION WAS NOT DEVICE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT NOTICED THAT THE SKIN ON HIS POCKET SITE WAS RED. THE PHYSICIAN DIAGNOSED THE REDNESS AS NON-DEVICE RELATED CELLULITIS. THE PATIENT WAS PRESCRIBED WITH AN ORAL ANTIBIOTIC.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT NOTICED THAT THE SKIN ON HIS POCKET SITE WAS RED. THE PHYSICIAN DIAGNOSED THE REDNESS AS NON-DEVICE RELATED CELLULITIS. THE PATIENT WAS PRESCRIBED WITH AN ORAL ANTIBIOTIC.

    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 47 YR Required Intervention