BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3902977 · Received June 30, 2014

    Report

    Report Number
    3006630150-2014-01488
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    April 21, 2014
    Report Date
    June 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN CONFIRMED THAT THE SHUTTING DOWN OF ORGANS, SWELLING OF PATIENT EVERYWHERE AND NO BOWEL MOVEMENT AFTER THE IMPLANT PROCEDURE WAS NOT CAUSE BY THE DEVICE OR THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#: SC-1110-02, SERIAL#: (B)(4), DESCRIPTION:PRECISION IMPLANTABLE PULSE GENERATOR (IPG) THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S ORGANS HAD SHUT DOWN AND THE PATIENT WAS EXPERIENCING SWELLING EVERYWHERE AND NO BOWEL MOVEMENT AFTER THE IMPLANT PROCEDURE. THE PATIENT WENT INTO THE EMERGENCY ROOM AND WAS PRESCRIBED LAXATIVE TO HAVE BOWEL MOVEMENT. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S ORGANS HAD SHUT DOWN AND THE PATIENT WAS EXPERIENCING SWELLING EVERYWHERE AND NO BOWEL MOVEMENT AFTER THE IMPLANT PROCEDURE. THE PATIENT WENT INTO THE EMERGENCY ROOM AND WAS PRESCRIBED LAXATIVE TO HAVE BOWEL MOVEMENT. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. NO DEVICE MALFUNCTION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379194 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention