BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3090753 · Received May 2, 2013

    Report

    Report Number
    3006630150-2013-00859
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    January 17, 2013
    Report Date
    April 10, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL / LOT #: (B)(4)/363560 DESCRIPTION: LINEAR ST LEAD, 50CM MODEL #: SC-3138-35, SERIAL / LOT #: (B)(4)/A49307, DESCRIPTION: SCS PHIII EXT 35CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS STILL HAVING PAIN AND BURNING SENSATION AT THE POCKET SITE AFTER A PREVIOUS REVISION (MFR REPORT #: 3006630150-2012-00322). THE PHYSICIAN SUSPECTED AN INFECTION BUT WAS NOT CONFIRMED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL AFTER THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192392 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention