BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3133261 · Received May 29, 2013

    Report

    Report Number
    3006630150-2013-01070
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2208-70, SERIAL/LOT #: (B)(4), DESCRIPTION: ST LINEAR LEAD 70CM.

    Additional Manufacturer Narrative · 1

    CORRECTION TO INITIAL MDR IN FIELDS: DEVICE INFO, IMPLANT, EXPLANT, EXPIRATION DATE,AND DEVICE MANUFACTURE DATE = NA INFORMATION RECEIVED CLARIFIED THAT THE PATIENT¿S EXPLANT WAS FOR A COMPETITOR DEVICE AND NOT FOR HER BOSTON SCIENTIFIC DEVICE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE. REASON FOR EXPLANT IS UNKNOWN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE. REASON FOR EXPLANT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234703 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention