BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2061174 · Received April 18, 2011

    Report

    Report Number
    3006630150-2011-00541
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 26, 2011
    Report Date
    March 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN DOESN'T BELIEVE THE PAIN WAS RELATED TO THE DEVICE. THE PAIN INJECTIONS WERE ADMINISTERED TO TREAT PRE EXISTING PAIN. A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED LEAD REVEALED NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE REPORTED EVENT OCCURRED DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT TRIAL PATIENT WAS EXPERIENCING PAIN AT THE LEAD SITE FOLLOWING THE IMPLANT PROCEDURE. THE PATIENT'S TRIAL LEADS WERE PULLED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WILL BE GIVEN PAIN INJECTIONS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT TRIAL PATIENT WAS EXPERIENCING PAIN AT THE LEAD SITE FOLLOWING THE IMPLANT PROCEDURE. THE PATIENT'S TRIAL LEADS WERE PULLED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WILL BE GIVEN PAIN INJECTIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R