BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3200497 · Received July 1, 2013

    Report

    Report Number
    3006630150-2013-01336
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY CHARGING THE IPG AND WAS EXPERIENCING PAIN AT THE POCKET SITE. DATABASE ANALYSIS REVEALED THAT THE IPG MAY BE FLIPPED. THE PATIENT UNDERWENT A POCKET REVISION WHEREIN THE IPG WAS RELOCATED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300038 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention