BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2080775 · Received May 6, 2011

    Report

    Report Number
    3006630150-2011-00678
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 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
    WA, AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE DEVICE FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION RECORDS OF THE DEVICE FOUND THEM TO BE SATISFACTORY

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT UNDERWENT A LEAD REVISION PROCEDURE AS THE LEAD INCISION SITE WAS CAUSING IRRITATION. NO INFECTION WAS PRESENT AT THE TIME, AS THE PATIENT WAS TREATED FOR A POTENTIAL INFECTION WITH ANTIBIOTICS A FEW WEEKS PRIOR. THE PHYSICIAN REVISED THE LEAD AWAY FROM THE IRRITATED AREA. NOTHING WAS IMPLANTED OR EXPLANTED AND THE PATIENT IS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT UNDERWENT A LEAD REVISION PROCEDURE AS THE LEAD INCISION SITE WAS CAUSING IRRITATION. NO INFECTION WAS PRESENT AT THE TIME, AS THE PATIENT WAS TREATED FOR A POTENTIAL INFECTION WITH ANTIBIOTICS A FEW WEEKS PRIOR. THE PHYSICIAN REVISED THE LEAD AWAY FROM THE IRRITATED AREA. NOTHING WAS IMPLANTED OR EXPLANTED AND 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-2366-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention