BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1000430 · Received February 21, 2008

    Report

    Report Number
    2029203-2008-00067
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 22, 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
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PRODUCTS WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF STERILIZATION RECORDS FOR THE IPG AND LEAD FOUND THEM TO BE SATISFACTORY. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE PT SYSTEM WAS EXPLANTED DUE TO INFECTION. THE PT WAS IMPLANTED WITH A NEW BOSTON SCIENTIFIC SPINAL CORD STIMULATOR SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention SC-3108-35| EXPLANTED: