BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2132943 · Received June 17, 2011

    Report

    Report Number
    3006630150-2011-00926
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL# SC-2138-50 SERIAL# (B)(4) DESCRIPTION: LINEAR LEAD, 50 CM WITH PRE-LOADED 0.012 INCHES STYLET.

    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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WOULD UNDERGO AN EXPLANT. THE PATIENT'S ANCHORS WERE BULGING IN THE LOWER BACK CAUSING PAIN. IN ADDITION THE PATIENT NEEDS TO PROCEED WITH MRIS AND THE DEVICE WAS NOT PROVIDING ADEQUATE PAIN RELIEF. THE PHYSICIAN WILL NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE EXPLANT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WOULD UNDERGO AN EXPLANT. THE PATIENT'S ANCHORS WERE BULGING IN THE LOWER BACK CAUSING PAIN. IN ADDITION, THE PATIENT NEEDS TO PROCEED WITH MRIS AND THE DEVICE WAS NOT PROVIDING ADEQUATE PAIN RELIEF. THE PHYSICIAN WILL NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2138-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention