BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2151740 · Received July 6, 2011

    Report

    Report Number
    3006630150-2011-00999
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING A SHOCKING SENSATION AND WARMTH OVER THE IPG SITE WHILE SHE WAS CHARGING. THE ANALYSIS OF THE IPG DATABASE REVEALED NO ANOMALIES IN REGARDS TO THE INTERNAL TEMPERATURE AND CHARGE CURRENT MEASUREMENTS. THE PHYSICIAN ELECTED TO RELOCATE THE POCKET. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention