BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2101096 · Received May 24, 2011

    Report

    Report Number
    3006630150-2011-00752
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 IPG FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE POCKET SITE. THE PATIENT'S SYMPTOMS INCLUDED REDNESS AND CLEAR DRAINAGE. THE PHYSICIAN BELIEVES THE INFECTION WAS PROCEDURE RELATED. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS. AFTER A FOLLOW UP APPOINTMENT THE PHYSICIAN REPORTED THAT IT WAS MORE A SKIN INFECTION/SUTURE ABSCESS AND THE PATIENT WAS DOING BETTER.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE POCKET SITE. THE PATIENT'S SYMPTOMS INCLUDED REDNESS AND CLEAR DRAINAGE. THE PHYSICIAN BELIEVES THE INFECTION WAS PROCEDURE RELATED. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS. AFTER A FOLLOW UP APPOINTMENT THE PHYSICIAN REPORTED THAT IT WAS MORE A SKIN INFECTION/SUTURE ABSCESS AND THE PATIENT WAS DOING BETTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention