BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3031651 · Received April 2, 2013

    Report

    Report Number
    3006630150-2013-00593
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IPG. X-RAY WAS TAKEN AND REVEALED IPG MIGRATION WHEREIN THE IPG HAD FLIPPED ON A SIDE. THE PATIENT UNDERWENT REVISION WHEREIN THE IPG WAS PLACED IN A NEW POCKET SITE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IPG. X-RAY WAS TAKEN AND REVEALED IPG MIGRATION WHEREIN THE IPG HAD FLIPPED ON A SIDE. THE PATIENT UNDERWENT REVISION WHEREIN THE IPG WAS PLACED IN A NEW POCKET SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134046 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention