BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2220673 · Received August 23, 2011

    Report

    Report Number
    3006630150-2011-01309
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    April 18, 2011
    Report Date
    July 28, 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

    A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE EXPLANTED DEVICES FOUND THEM TO BE SATISFACTORY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#:SC-2218-70, SERIAL#:(B)(4), DESCRIPTION:ENH ST LD KIT,70 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED MRSA FOLLOWING A LEAD REVISION PROCEDURE. THE INFECTION WAS LOCATED AT THE LEAD INCISION SITE. THE PHYSICIAN DOES NOT BELIEVE THE INFECTION WAS DEVICE RELATED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND WILL BE MONITORED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DEVELOPED MRSA FOLLOWING A LEAD REVISION PROCEDURE. THE INFECTION WAS LOCATED AT THE LEAD INCISION SITE. THE PHYSICIAN DOES NOT BELIEVE THE INFECTION WAS DEVICE RELATED. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention