BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2192713 · Received August 5, 2011

    Report

    Report Number
    3006630150-2011-01132
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S INFECTION HAD CLEARED AND THAT THE PHYSICIAN WILL TAKE NO FURTHER ACTION. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG AND PADDLE LEAD REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE IPG AND PADDLE LEAD FOUND THEM TO BE SATISFACTORY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#:SC-8216-70 SERIAL#: (B)(4) MODEL DESCRIPTION: ARTISAN 2X8 PADDLE LEAD (LIM), 70 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED AN INFECTION AT THE IPG AND LEAD SITES. THE PHYSICIAN NOTICED SWELLING AT THE IPG SITE AND PRESCRIBED VANCOMYCIN AND AN IV ANTIBIOTIC.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED AN INFECTION AT THE IPG AND LEAD SITES. THE PHYSICIAN NOTICED SWELLING AT THE IPG SITE AND PRESCRIBED VANCOMYCIN AND AN IV ANTIBIOTIC.

    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 Required Intervention