BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2233245 · Received September 2, 2011

    Report

    Report Number
    3006630150-2011-01374
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    July 31, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS PRESCRIBED A REGIME OF ANTIBIOTICS AND IS REPORTEDLY DOING FINE. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE DEVICES FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION RECORDS OF THE DEVICES FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD SWELLING AND PUS AT THE LEAD SITE. THE PHYSICIAN IS UNSURE IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS GIVEN IV ANTIBIOTICS, HOWEVER, THE SYMPTOMS HAD NOT SUBSIDED. THE PATIENT WILL FOLLOW UP WITH AN INFECTIOUS DISEASE PHYSICIAN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD SWELLING AND PUS AT THE LEAD SITE. THE PHYSICIAN IS UNSURE IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS GIVEN IV ANTIBIOTICS, HOWEVER, THE SYMPTOMS HAD NOT SUBSIDED. THE PATIENT WILL FOLLOW UP WITH AN INFECTIOUS DISEASE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R