BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3003016 · Received March 13, 2013

    Report

    Report Number
    3006630150-2013-00440
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 11, 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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG, LEADS, AND LEAD EXTENSIONS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE DEVICES WAS FOUND TO BE SATISFACTORY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-50, SERIAL / LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50 CM MODEL #: SC-3138-35, SERIAL / LOT #: (B)(4), DESCRIPTION: SCS PHIII EXT 35 CM. 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 WAS EXPERIENCING SORENESS AND PAIN AT THE POCKET SITE. PRESENCE OF OPEN, OOZING WOUND OVER THE POCKET SITE, EXPOSING THE BATTERY WAS NOTED. WOUND DRESSING WAS DONE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ONE LEAD WAS NOT REMOVED DUE TO PRESENCE OF SCAR TISSUE. THE PATIENT REMAINED IN THE HOSPITAL UNTIL THE LEAD WILL BE REMOVED. INTRAVENOUS ANTIBIOTIC WAS GIVEN TO THE PATIENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING SORENESS AND PAIN AT THE POCKET SITE. PRESENCE OF OPEN, OOZING WOUND OVER THE POCKET SITE, EXPOSING THE BATTERY WAS NOTED. WOUND DRESSING WAS DONE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ONE LEAD WAS NOT REMOVED DUE TO PRESENCE OF SCAR TISSUE. THE PATIENT REMAINED IN THE HOSPITAL UNTIL THE LEAD WILL BE REMOVED. INTRAVENOUS ANTIBIOTIC WAS GIVEN TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104959 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R