BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3900524 · Received June 27, 2014

    Report

    Report Number
    3006630150-2014-01459
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-8216-50, SERIAL #: (B)(4), DESCRIPTION: ARTISAN SURGICAL LEAD, 50CM. MODEL #: SC-1132, SERIAL #: (B)(4), DESCRIPTION: PRECISION SPECTRA IMPLANTABLE PULSE GENERATOR. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED AN INFECTION AT THE MIDLINE CERVICAL INCISION SITE. SYMPTOMS INCLUDED PUS COMING OUT OF THE SITE AND SEVERE PAIN AT BOTH INCISIONS. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE RELATED AND THAT IT WAS DUE TO PATIENT BEING OVERWEIGHT AND HAVING MULTIPLE INCISIONS. THE PATIENT WAS PRESCRIBED KEFLEX AND UNDERWENT AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED AN INFECTION AT THE MIDLINE CERVICAL INCISION SITE. SYMPTOMS INCLUDED PUS COMING OUT OF THE SITE AND SEVERE PAIN AT BOTH INCISIONS. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE RELATED AND THAT IT WAS DUE TO PATIENT BEING OVERWEIGHT AND HAVING MULTIPLE INCISIONS. THE PATIENT WAS PRESCRIBED KEFLEX AND UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377575 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention