BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2103200 · Received May 25, 2011

    Report

    Report Number
    3006630150-2011-00761
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 27, 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

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING. X-RAY REVEALED THAT THE IPG HAD FLIPPED INSIDE THE POCKET. THE PHYSICIAN DECIDED TO REVISE THE POCKET SITE BUT THE PROCEDURE WAS CANCELLED DUE TO INSURANCE ISSUES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING. X-RAY REVEALED THAT THE IPG HAD FLIPPED INSIDE THE POCKET. THE PHYSICIAN DECIDED TO REVISE THE POCKET SITE BUT THE PROCEDURE WAS CANCELLED DUE TO INSURANCE ISSUES.

    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 41 YR Required Intervention