BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2101345 · Received May 24, 2011

    Report

    Report Number
    3006630150-2011-00754
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    March 15, 2011
    Report Date
    April 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 A PATIENT HAD AN INFECTION AT THE MIDLINE INCISION SITE. THE PHYSICIAN PRESCRIBED THE PATIENT ORAL ANTIBIOTICS AND THE INFECTION HAS SINCE CLEARED. THE PATIENT IS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT HAD AN INFECTION AT THE MIDLINE INCISION SITE. THE PHYSICIAN PRESCRIBED THE PATIENT ORAL ANTIBIOTICS AND THE INFECTION HAS SINCE CLEARED. THE PATIENT IS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT HAD AN INFECTION AT THE MIDLINE INCISION SITE. THE PHYSICIAN PRESCRIBED THE PATIENT ORAL ANTIBIOTICS AND THE INFECTION HAS SINCE CLEARED. THE PATIENT IS REPORTEDLY DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention