BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3230498 · Received July 16, 2013

    Report

    Report Number
    3006630150-2013-01490
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM. 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 UNDERWENT AN EXPLANT PROCEDURE DUE TO SUSPECTED INFECTION AT THE POCKET AND MIDLINE INCISION SITES. THE PATIENT WAS EXPERIENCING FLU-LIKE SYMPTOMS AND HEADACHE. DURING THE EXPLANT PROCEDURE, THE WOUNDS WERE CLEANED. THE PHYSICIAN DOES NOT BELIEVE THE INFECTION WAS DEVICE RELATED. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE AND WAS ON ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329138 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention