BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3232099 · Received July 17, 2013

    Report

    Report Number
    3006630150-2013-01489
    Event Type
    Injury
    Date Received
    July 17, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTION WAS NOT DEVICE NOR PROCEDURE RELATED, THE PATIENT IS DIABETIC AND MORE PRONE TO INFECTION. THE INFECTION HAS NOT COMPLETELY CLEARED UP. THE PATIENT IS STILL BEING TREATED WITH INTRAVENOUS ANTIBIOTICS.

    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. 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 UNDERWENT AN EXPLANT PROCEDURE DUE TO INFECTION AT THE IPG SITE. INITIAL SYMPTOMS WERE FEVER AND DRAINAGE AT THE POCKET SITE. THE PATIENT WAS ADMITTED IN THE HOSPITAL AND WAS GIVEN ORAL AND IV ANTIBIOTICS. THE PATIENT'S CONDITION WAS IMPROVING AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INFECTION AT THE IPG SITE. INITIAL SYMPTOMS WERE FEVER AND DRAINAGE AT THE POCKET SITE. THE PATIENT WAS ADMITTED IN THE HOSPITAL AND WAS GIVEN ORAL AND IV ANTIBIOTICS. THE PATIENT'S CONDITION WAS IMPROVING AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332501 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R