BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2863299 · Received December 10, 2012

    Report

    Report Number
    3006630150-2012-02289
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-2366-50, SERIAL: (B)(4), DESCRIPTION: LINEAR 3-6 LEAD, 50CM; MODEL: SC-2366-70, SERIAL: (B)(4), DESCRIPTION: LINEAR 3-6 LEAD, 70CM; MODEL: SC-3354-25, SERIAL: (B)(4), DESCRIPTION: W4 SPLITTER 2X4-25CM. IT IS INDICATED THAT THE DEVICES 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED AN INFECTION AT THE POCKET AND LEAD SITES. THE PATIENT EXPERIENCED FLU-LIKE SYMPTOMS. THE PATIENT WAS HOSPITALIZED AND GIVEN VANCOMYCIN IV ANTIBIOTICS AND ORAL ANTIBIOTICS. THE PHYSICIAN BELIEVES THAT THE INFECTION WAS DEVICE AND PROCEDURE RELATED. THE PATIENT IS REPORTEDLY DOING WELL AND THE INFECTION HAS RESOLVED.

    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 Hospitalization| R