BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 4123792 · Received September 26, 2014

    Report

    Report Number
    3006630150-2014-02209
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2208-30 SERIAL/LOT #: (B)(4), DESCRIPTION: ST LINEAR LEAD 30CM MODEL #: SC-3138-35, SERIAL/LOT #: (B)(4), DESCRIPTION: SCS PHIII EXT 35CM. 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 A PROCEDURE RELATED INFECTION AT THE IPG SITE. THE POCKET WAS RED AND HAD PUS. THE PATIENT WAS ADMINISTERED WITH INTRAVENOUS ANTIBIOTIC AND UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602664 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention