BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3011611 · Received March 19, 2013

    Report

    Report Number
    3006630150-2013-00470
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2316-50E, SERIAL / LOT #: (B)(4), DESCRIPTION: INFINION 1X16 PERC LEAD AND SPLITTER 2X8 KITS. THE EXPLANTED DEVICE WAS NOT RETURNED TO BSN AS IT WAS 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 TRIAL PATIENT WENT TO THE EMERGENCY ROOM DUE TO INFECTION AT THE SURGICAL SITE. THE PATIENT'S SYMPTOMS INCLUDE PAIN, FEVER, REDNESS AND SWELLING AT THE SURGICAL SITE. THE PHYSICIAN DID NOT DISCLOSE ANY INFORMATION IF INFECTION WAS DEVICE OR PROCEDURE RELATED. LEAD PULL WAS DONE AND THE PATIENT WAS GIVEN ORAL ANTIBIOTICS FOR THE INFECTION. THE PATIENT WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114135 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention