BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2073116 · Received April 29, 2011

    Report

    Report Number
    3006630150-2011-00580
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    September 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING CHARGING DIFFICULTIES DUE TO THE IPG TURNING IN THE POCKET. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG TURNED TO THE CORRECT ORIENTATION AND FIXED IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention