BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2021613 · Received March 17, 2011

    Report

    Report Number
    3006630150-2011-00357
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    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-8216-50 (B)(4) MODEL DESCRIPTION: ARTISAN 2X8 PADDLE LEAD (LIM), 50 CM ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN DID NOT THINK THAT THE INFECTION WAS DEVICE OR PROCEDURE RELATED SINCE THE INFECTION HAPPENED ABOUT 3 MONTHS AFTER THE PATIENT WAS IMPLANTED AND THE IMPLANT WOUNDS HAD HEALED IN THAT TIME. THE PHYSICIAN REPORTED THAT THE WOUNDS HAD OPENED BACK UP FOR AN UNKNOWN REASON. THE PATIENT WAS ALSO GIVEN IV ANTIBIOTICS AND IS DOING WELL. 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'S WOUND AT THE POCKET SITE HAD NOT FULLY HEALED FOLLOWING THE IMPLANT PROCEDURE. THE PATIENTS SYMPTOMS INCLUDED DRAINAGE AND A HOLE THE DIAMETER OF A PENCIL AT THE POCKET SITE. THE PHYSICIAN PRESCRIBED THE PATIENT ORAL ANTIBIOTICS AND TREATED THE POCKET SITE WITH BETADINE SOLUTION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S WOUND AT THE POCKET SITE HAD NOT FULLY HEALED FOLLOWING THE IMPLANT PROCEDURE. THE PATIENTS SYMPTOMS INCLUDED DRAINAGE AND A HOLE THE DIAMETER OF A PENCIL AT THE POCKET SITE. THE PHYISICAN PRESCRIBED THE PATIENT ORAL ANTIBIOTICS AND TREATED THE POCKET SITE WITH BETADINE SOLUTION.

    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 40 YR Required Intervention