BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3142865 · Received June 3, 2013

    Report

    Report Number
    3006630150-2013-01138
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE TO THE INITIAL MDR IN FIELDS: ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR THE PATIENT'S EXPLANT PROCEDURE WAS DUE TO ELECTIVE REASONS. NO DEVICE MALFUNCTION WAS SUSPECTED. THE PATIENT IS REPORTEDLY DOING WELL. THE RETURNED PRODUCT ANALYSIS INDICATED THAT THE IPG PASSED ELECTRICAL, PERFORMANCE AND VISUAL INSPECTION TEST PERFORMED. THE IPG EXHIBITS NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS EXPLANTED. THE REASON FOR THE EXPLANT IS UNKNOWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS EXPLANTED. THE REASON FOR THE EXPLANT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243364 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention