BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2990401 · Received March 5, 2013

    Report

    Report Number
    3006630150-2013-00368
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    October 30, 2012
    Report Date
    February 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THE EVENT WAS NOT DEVICE RELATED BUT WAS PROCEDURE RELATED.

    Additional Manufacturer Narrative · 1

    EVENT DATE: SHOULD HAVE BEEN: (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    THE RETURNED IPG PASSED VISUAL, ELECTRIAL AND PERFORMANCE TESTING. THE IPG EXHIBITS NORMAL DEVICE CHARACTERISTICS. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE EXPLANTED IPG FOUND THE DEVICE TO BE SATISFACTORY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTION IS RELATED TO THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT HAD DEVELOPED AN INFLAMED POCKET SITE. THE PATIENT WAS HOSPITALIZED AND EXPLANTED DUE TO AN INFECTION. THE PATIENT WAS ALSO TREATED WITH ANTIBIOTICS. THE EVENT WAS RESOLVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT HAD DEVELOPED AN INFLAMED POCKET SITE. THE PATIENT WAS HOSPITALIZED AND EXPLANTED DUE TO AN INFECTION. THE PATIENT WAS ALSO TREATED WITH ANTIBIOTICS. THE EVENT WAS RESOLVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT HAD DEVELOPED AN INFLAMED POCKET SITE. THE PATIENT WAS HOSPITALIZED AND EXPLANTED DUE TO AN INFECTION. THE PATIENT WAS ALSO TREATED WITH ANTIBIOTICS. THE EVENT WAS RESOLVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT HAD DEVELOPED AN INFLAMED POCKET SITE. THE PATIENT WAS HOSPITALIZED AND EXPLANTED DUE TO AN INFECTION. THE PATIENT WAS ALSO TREATED WITH ANTIBIOTICS. THE EVENT WAS RESOLVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT HAD DEVELOPED AN INFLAMED POCKET SITE. THE PATIENT WAS HOSPITALIZED AND EXPLANTED DUE TO AN INFECTION. THE PATIENT WAS ALSO TREATED WITH ANTIBIOTICS. THE EVENT WAS RESOLVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT HAD DEVELOPED AN INFLAMED POCKET SITE. THE PATIENT WAS HOSPITALIZED AND EXPLANTED DUE TO AN INFECTION. THE PATIENT WAS ALSO TREATED WITH ANTIBIOTICS. THE EVENT WAS RESOLVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93654 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R