BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1961043 · Received January 11, 2011

    Report

    Report Number
    3006630150-2011-00032
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG WAS NOT RETURNED TO BSN AS IT WAS KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WSS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION DUE TO EXPERIENCING PAIN AT THE POCKET SITE AND DIFFICULTY CHARGING THE IPG. THE PHYSICIAN CHOSE TO REPLACE THE IPG BECAUSE AT THE TIME OF THE PROCEDURE THE IPG WAS IN HIBERNATION MODE. THE DEVICE WAS WORKING PROPERLY. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION DUE TO EXPERIENCING PAIN AT THE POCKET SITE AND DIFFICULTY CHARGING THE IPG. THE PHYSICIAN CHOSE TO REPLACE THE IPG BECAUSE AT THE TIME OF THE PROCEDURE, THE IPG WAS IN HIBERNATION MODE. THE DEVICE WAS WORKING PROPERLY. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention