BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1253098 · Received December 5, 2008

    Report

    Report Number
    2029203-2008-01019
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 5, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY, THEREFORE, THEY WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A REPORT OF AN INFECTION AT THE PATIENT'S LEAD SITE WAS RECEIVED. THE PATIENT'S PRECISION SYSTEM WAS EXPLANTED, DUE TO THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORP SC-8120-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTABLE PULSE GENERATOR