BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2130131 · Received June 16, 2011

    Report

    Report Number
    3006630150-2011-00918
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL# SC-2218-50 SERIAL# (B)(4) DESCRIPTION: ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014 INCHES STYLET.

    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'S INCISION SITE HAD NOT HEALED PROPERLY. THE PHYSICIAN REMOVED THE TISSUE AROUND THE MIDLINE INCISION AND STITCHED THE AREA BACK UP. THE PATIENT WAS GIVEN ANTIBIOTICS AS A PREVENTATIVE, THOUGH THE AREA DID NOT LOOK INFECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT'S INCISION SITE HAD NOT HEALED PROPERLY. THE PHYSICIAN REMOVED THE TISSUE AROUND THE MIDLINE INCISION AND STITCHED THE AREA BACK UP. THE PATIENT WAS GIVEN ANTIBIOTICS AS A PREVENTATIVE, THOUGH THE AREA DID NOT LOOK INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Required Intervention