BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1903152 · Received November 17, 2010

    Report

    Report Number
    3006630150-2010-01999
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN FOR ANALYSIS AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO A SUSPECTED INFECTION. THE PATIENT'S SYMPTOMS INCLUDED PAIN. THE PHYSICIAN EXPLANTED THE PATIENT AND DID NOT FIND ANY INFECTION DURING THE PROCEDURE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AS A PRECAUTION.

    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 39 YR Required Intervention MODEL # SC-8216-50, SERIAL # (B)(4)| 50 CM| ARTISAN SURGICAL LEAD WITH PLATNALOCK TECHNOLOGY