BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2122290 · Received June 13, 2011

    Report

    Report Number
    3006630150-2011-00898
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 18, 2010
    Report Date
    May 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE DEVICE 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 WAS EXPERIENCING PAIN AT THE IPG SITE. THE PATIENT WAS PRESCRIBED OXYCODONE AND OPANA FOR THE PAIN. A GOOD FAITH EFFORT WAS MADE TO FOLLOW UP WITH THE PATIENT BUT THE ATTEMPTS WERE UNSUCCESSFUL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE. THE PATIENT WAS PRESCRIBED OXYCODONE AND OPANA FOR THE PAIN. A GOOD FAITH EFFORT WAS MADE TO FOLLOW UP WITH THE PATIENT BUT THE ATTEMPTS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention