BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2120635 · Received June 10, 2011

    Report

    Report Number
    3006630150-2011-00873
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IS CONTINUING TO IMPROVE AND NO FURTHER COURSE OF ACTION IS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER AND EXPIRATION DATE OF THE PRODUCT ARE UNKNOWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN REPORTED THAT THE PATIENT HAD POCKETS OF PUS AROUND THE IPG AND LEAD SITE. THE PATIENT UNDERWENT AN EXPLANT AND IS REPORTEDLY DOING WELL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: SC-8116-70, SERIAL: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 70CM. EXPLANTED PADDLE LEAD WILL NOT BE RETURNED TO BSN AS IT WAS DISCARDED BY MEDICAL FACILITY. 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 MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT AFTER AN ULTRASOUND GUIDED ASPIRATION OF THE WOUND, A COMMUNICATING SINUS WAS FOUND WITH NO POCKET FLUID. A SUPERFICIAL SWAB INDICATED (B)(6). THE PHYSICIAN BELIEVES THAT THE INFECTION IS DEVICE RELATED AND PLANS TO START THE PATIENT ON (B)(6) AND (B)(6) AND (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REVEALED THAT THE INFECTUOUS DISEASE PHYSICIAN WILL CONTINUE TO TREAT THE PATIENT MEDICALLY AND WITHOUT THE NEED FOR SURGICAL INTERVENTION. 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 EXPLANTED DEVICES FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG SITE WAS INFECTED. THE SYMPTOMS OF INFECTION WERE REDNESS AND DRAINAGE. THE PHYSICIAN PLACED THE PATIENT ON ANTIBIOTICS AND WAS REFERRED TO AN INFECTIOUS DISEASE PHYSICIAN FOR FURTHER TESTING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG SITE WAS INFECTED. THE SYMPTOMS OF INFECTION WERE REDNESS AND DRAINAGE. THE PHYSICIAN PLACED THE PATIENT ON ANTIBIOTICS AND WAS REFERRED TO AN INFECTIOUS DISEASE PHYSICIAN FOR FURTHER TESTING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG SITE WAS INFECTED. THE SYMPTOMS OF INFECTION WERE REDNESS AND DRAINAGE. THE PHYSICIAN PLACED THE PATIENT ON ANTIBIOTICS AND WAS REFERRED TO AN INFECTIOUS DISEASE PHYSICIAN FOR FURTHER TESTING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG SITE WAS INFECTED. THE SYMPTOMS OF INFECTION WERE REDNESS AND DRAINAGE. THE PHYSICIAN PLACED THE PATIENT ON ANTIBIOTICS AND WAS REFERRED TO AN INFECTIOUS DISEASE PHYSICIAN FOR FURTHER TESTING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG SITE WAS INFECTED. THE SYMPTOMS OF INFECTION WERE REDNESS AND DRAINAGE. THE PHYSICIAN PLACED THE PATIENT ON ANTIBIOTICS AND WAS REFERRED TO AN INFECTIOUS DISEASE PHYSICIAN FOR FURTHER TESTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention