BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2222085 · Received August 24, 2011

    Report

    Report Number
    3006630150-2011-01305
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    June 16, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT HAVE AN INFECTION. THE FLUID IN THE LUNGS WAS DUE TO THE PATIENT'S DIABETES AS WAS THE SLOW HEALING OF THE POCKET SITE. NO TREATMENT WAS PROVIDED AND THE PATIENT WAS REPORTEDLY DOING WELL. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE IPG FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A WEEK AFTER BEING IMPLANTED THE PATIENT WAS HOSPITALIZED DUE TO FLUID IN HIS LUNGS AND AN INFECTION AT THE POCKET SITE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A WEEK AFTER BEING IMPLANTED THE PATIENT WAS HOSPITALIZED DUE TO FLUID IN HIS LUNGS AND AN INFECTION AT THE POCKET SITE.

    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