BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2110663 · Received June 1, 2011

    Report

    Report Number
    3006630150-2011-00810
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT THE IMPLANT SITE. THE PATIENT REPORTED THAT WITH MOVEMENT OR PRESSURE, THE IPG MOVES ON HIS RIBS AND MAKES HIM FEEL LIKE HE HAS A BROKEN RIB. THE PATIENT WAS GIVEN PAIN MEDICATION AND THEN UNDERWENT A POCKET REVISION. THE PHYSICIAN MOVED THE IPG FROM THE RIGHT FLANK AREA TO THE LOWER BUTTOCK. THE PATIENT IS 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention