BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2123501 · Received June 14, 2011

    Report

    Report Number
    3006630150-2011-00870
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO INFECTION. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-2108-70M, (B)(4), MODEL DESCRIPTION: LINEAR LEAD, 70 CM WITH PRE-LOADED 0.012 INCH STYLET; MODEL#: SC-3108-35, (B)(4), MODEL DESCRIPTION: LEAD EXTENSION, 35 CM. A RETURN PRODUCT ANALYSIS INDICATED THAT THE IPG EXHIBITS NORMAL DEVICE CHARACTERISTICS. THE LEAD (SC-2108-70M (B)(4)) WAS INTACT AND NO PARTS OF IT ARE MISSING. THE ROOT CAUSE OF THE REPORTED POCKET PAIN IS UNKNOWN. NO ANOMALY WAS NOTED IN THE STERILIZATION RECORDS. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEAD EXTENSION (SC-3108-35 (B)(4)) FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO INFECTION. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#:SC-2108-70M, SERIAL#: (B)(4), MODEL DESCRIPTION: LINEAR LEAD, 70 CM WITH PRE-LOADED 0.012 INCH STYLET MODEL#: SC-3108-35, SERIAL#: (B)(4), MODEL DESCRIPTION: LEAD EXTENSION, 35 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG SITE WAS INFECTED. THE SYMPTOMS OF THE INFECTION WERE SENSITIVITY, PAIN, REDNESS AND SWELLING. THE PHYSICIAN DID NOT BELIEVE THAT THE INFECTION WAS DEVICE RELATED AND PRESCRIBED THE PATIENT ORAL ANTIBIOTICS. THE PATIENT WAS DOING FINE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG SITE WAS INFECTED. THE SYMPTOMS OF THE INFECTION WERE SENSITIVITY, PAIN, REDNESS AND SWELLING. THE PHYSICIAN DID NOT BELIEVE THAT THE INFECTION WAS DEVICE RELATED AND PRESCRIBED THE PATIENT ORAL ANTIBIOTICS. THE PATIENT WAS DOING FINE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG SITE WAS INFECTED. THE SYMPTOMS OF THE INFECTION WERE SENSITIVITY, PAIN, REDNESS AND SWELLING. THE PHYSICIAN DID NOT BELIEVE THAT THE INFECTION WAS DEVICE RELATED AND PRESCRIBED THE PATIENT ORAL ANTIBIOTICS. THE PATIENT WAS DOING FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention