BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2183118 · Received July 28, 2011

    Report

    Report Number
    3006630150-2011-01192
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WILL NOT UNDERGO AN IPG REVISION DUE TO NOT BEING COMPLIANT. 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING HER IPG. MULTIPLE CHARGING SESSIONS AND RE-EDUCATION BY THE BSN SALES REPRESENTATIVE DID NOT RESOLVE THE ISSUE. THE PATIENT WILL UNDERGO AN IPG REVISION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING HER IPG. MULTIPLE CHARGING SESSIONS AND RE-EDUCATION BY THE BSN SALES REPRESENTATIVE DID NOT RESOLVE THE ISSUE. THE PATIENT WILL UNDERGO AN IPG REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention