BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1864533 · Received October 6, 2010

    Report

    Report Number
    3006630150-2010-01672
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN BECAUSE THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT WAS EXPERIENCING DRAINAGE AT THE LEAD SITE. THE PHYSICIAN DISCOVERED AN ACTIVE INFECTION AT THE LEAD SITE AND DECIDED TO EXPLANT THE SCS SYSTEM. THE PHYSICIAN DID NOT FEEL THAT THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PT WAS PLACED ON GENERAL ANTIBIOTICS AND WAS REPORTEDLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8120-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention ARTISAN 2X8 PADDLE LEAD (WITH SLOTTED ELECTRODES)| MODEL# SC-1110-02| SERIAL#: (B)(4)| SERIAL# (B)(4)| 70CM, MODEL# SC-8120-70| IPG KIT (WITHOUT PULL-THROUGH TUNNELER)