BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3050862 · Received April 10, 2013

    Report

    Report Number
    3006630150-2013-00675
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-70, SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM; MODEL #: SC-2218-50, SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM. MODEL #: SC-3304-25, SERIAL/LOT #: (B)(4), DESCRIPTION: SPLITTER 2X4-25 CM, MODEL #: SC-3354-25, SERIAL/LOT #: (B)(4), DESCRIPTION: W4 SPLITTER 2X4-25 CM; MODEL #: SC-4316, SERIAL/LOT #: (B)(4), DESCRIPTION: NEXT GENERATION ANCHOR KIT-STERILE. 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 HAD INFECTION NEAR THE IPG SITE. PATIENT SYMPTOMS WERE DRAINAGE AND FEVER. THE PATIENT WAS GIVEN ORAL AND INTRAVENOUS ANTIBIOTICS. THE INFECTION WAS NEITHER DEVICE NOR PROCEDURE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE PATIENT WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149985 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention