BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2273093 · Received October 3, 2011

    Report

    Report Number
    3006630150-2011-01532
    Event Type
    Injury
    Date Received
    October 3, 2011
    Date of Event
    September 6, 2011
    Report Date
    September 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL AND PERFORMANCE TESTS PERFORMED. NO ANOMALIES WERE FOUND. DEVICE EVALUATION INDICATED THAT THE LEADS PASSED VISUAL TESTS PERFORMED. NO ANOMALIES WERE FOUND. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE IPG AND LEADS FOUND THEM TO BE SATISFACTORY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2218-30, SERIAL # (B)(4), DESCRIPTION: ST LINEAR LEAD, 30CM WITH PRE-LOADED 0.014 INCH STYLET.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO AN INFECTION AT THE POCKET AND LEAD SITES. THE PATIENT'S SYMPTOMS INCLUDED PRESSURE AND PAIN. THE PHYSICIAN DOES NOT BELIEVE THE INFECTION WAS DEVICE RELATED. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS AND WAS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO AN INFECTION AT THE POCKET AND LEAD SITES. THE PATIENT'S SYMPTOMS INCLUDED PRESSURE AND PAIN. THE PHYSICIAN DOES NOT BELIEVE THE INFECTION WAS DEVICE RELATED. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS AND WAS REPORTEDLY DOING WELL.

    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 Hospitalization| R