BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3103627 · Received May 9, 2013

    Report

    Report Number
    3006630150-2013-00921
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT HAVE AN INFECTION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2218-70, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM THE EXPLANTED IPG WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S POCKET SITE HAD OPENED AND THE PHYSICIAN BELIEVED THAT THE POCKET SITE MAY BE INFECTED. SYMPTOMS INCLUDE REDNESS, SWELLING AND DRAINAGE. THE PHYSICIAN REMOVED THE PATIENT'S IPG, IRRIGATED THE POCKET SITE WELL AND GAVE THE PATIENT INTRAVENOUS ANTIBIOTICS DURING THE PROCEDURE. THE PHYSICIAN BELIEVED THAT THE EVENT WAS NOT DEVICE RELATED AND THE CAUSE WAS THAT THE PATIENT DOES NOT HAVE A LOT OF FATTY TISSUE IN THE AREA. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S POCKET SITE HAD OPENED AND THE PHYSICIAN BELIEVED THAT THE POCKET SITE MAY BE INFECTED. SYMPTOMS INCLUDE REDNESS, SWELLING AND DRAINAGE. THE PHYSICIAN REMOVED THE PATIENT¿S IPG, IRRIGATED THE POCKET SITE WELL AND GAVE THE PATIENT INTRAVENOUS ANTIBIOTICS DURING THE PROCEDURE. THE PHYSICIAN BELIEVED THAT THE EVENT WAS NOT DEVICE RELATED AND THE CAUSE WAS THAT THE PATIENT DOES NOT HAVE A LOT OF FATTY TISSUE IN THE AREA. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202782 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention