BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2251511 · Received September 16, 2011

    Report

    Report Number
    3006630150-2011-01391
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECIVED THAT THE PATIENT WAS HAVING DIFFICULTY CHARGING DUE TO THE POCKET BEING TOO DEEP. THE PHYSICIAN REVISED THE IPG AND THE PATIENT WAS REPORTEDLY DOING FINE.

    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 Required Intervention