BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2191974 · Received August 4, 2011

    Report

    Report Number
    3006630150-2011-01205
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE IPG FOUND THEM TO BE SATISFACTORY.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO BSN BECAUSE IT WAS KEPT BY THE PATIENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED AS THE IPG WAS PROTRUDING OUT OF HIS SKIN FOLLOWING NON-DEVICE RELATED WEIGHT LOSS. THE DEVICE WAS WORKING PROPERLY PRIOR TO BEING EXPLANTED. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED AS THE IPG WAS PROTRUDING OUT OF HIS SKIN FOLLOWING NON-DEVICE RELATED WEIGHT LOSS. THE DEVICE WAS WORKING PROPERLY PRIOR TO BEING EXPLANTED. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention