BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2143458 · Received June 29, 2011

    Report

    Report Number
    3006630150-2011-00986
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN OPENED THE POCKET SITE AND TOOK A CULTURE. THE RESULTS WERE (B)(6). THE PHYSICIAN DID NOT EXPLANT THE IPG. THE PATIENT IS REPORTEDLY FEELING BETTER AND PHYSICIAN DOES NOT PLAN TO PROCEED WITH ANY FURTHER COURSE OF ACTION. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED DEVICES FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION RECORDS OF THE EXPLANTED DEVICES FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE LEAD SITE. THE PHYSICIAN DECIDED TO EXPLANT THE IPG SUSPECTING INFECTION. THE PATIENT WAS PRESCRIBED AN ORAL ANTIBIOTIC.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE LEAD SITE. THE PHYSICIAN DECIDED TO EXPLANT THE IPG SUSPECTING INFECTION. THE PATIENT WAS PRESCRIBED AN ORAL ANTIBIOTIC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention