BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1222018 · Received November 6, 2008

    Report

    Report Number
    2029203-2008-00900
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WILL NOT BE EVALUATED AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A PATIENT'S PRECISION SYSTEM WAS EXPLANTED DUE TO A STAPH INFECTION IN THE PATIENT'S THORACIC SPINE AND THE IPG POCKET SITE. THE PHYSICIAN DID NOT BELIEVE THE INFECTION WAS DEVICE RELATED. THE PATIENT WAS ADMINISTERED IV ANTIBIOTICS. THE PATIENT IS REPORTEDLY DOING WELL AND THE INFECTION HAS CLEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1110 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MODEL # SC-8120-50| ARTISAN 2X8 PADDLE LEAD (WITH SLOTTED ELECTRODES):