BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2113124 · Received June 3, 2011

    Report

    Report Number
    3006630150-2011-00821
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE IPG REVEALED NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE REPORTED EVENT OCCURRED DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG WILL NOT BE RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS EXPLANTED DUE TO THE STIMULATION MAKING THE PATIENT'S PAIN WORSE AND DISCOMFORT AT THE POCKET SITE WHEN THE PATIENT SITS. THE PATIENT HAD RECENT WEIGHT LOSS, NOT DEVICE RELATED, WHICH CAUSED THE IPG SITE DISCOMFORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S IPG WAS EXPLANTED DUE TO THE STIMULATION MAKING THE PATIENT'S PAIN WORSE AND DISCOMFORT AT THE POCKET SITE WHEN THE PATIENT SITS. THE PATIENT HAD RECENT WEIGHT LOSS, NOT DEVICE RELATED, WHICH CAUSED THE IPG SITE DISCOMFORT.

    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 46 YR Required Intervention