BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1971498 · Received January 21, 2011

    Report

    Report Number
    3006630150-2011-00086
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED IPG WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT WAS EXPLANTED DUE TO AN INFECTION AT THE POCKET SITE. THE PT'S SYMPTOMS WERE FEVER AND PUS. THE PHYSICIAN LEFT THE LEADS IMPLANTED FOR FUTURE RE-IMPLANT. THE PT WAS PRESCRIBED IV ANTIBIOTICS AND LONG TERM ORAL ANTIBIOTICS. THE PHYSICIAN BELIEVES THE INFECTION IS NOT DEVICE RELATED BUT RELATED TO THE PT NOT HANDLING THE WOUND CARE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Required Intervention