BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2132681 · Received June 17, 2011

    Report

    Report Number
    3006630150-2011-00911
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED DEVICES FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#:SC-2138-70 (B)(4) MODEL DESCRIPTION:LINEAR LEAD, 70 CM WITH PRE-LOADED 0.012 INCH STYLET.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND DIFFICULTY CHARGING. HIGH IMPEDANCES WERE OBSERVED ON THE PATIENT'S LEAD AND THE PHYSICIAN DECIDED TO EXPLANT THE PERCUTANEOUS LEADS AND IMPLANT A PADDLE LEAD. THE PATIENT WAS REPORTEDLY DOING FINE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION AND DIFFICULTY CHARGING. HIGH IMPEDANCES WERE OBSERVED ON THE PATIENT'S LEAD AND THE PHYSICIAN DECIDED TO EXPLANT THE PERCUTANEOUS LEADS AND IMPLANT A PADDLE LEAD. THE PATIENT WAS REPORTEDLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2138-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention