BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 2000967 · Received February 18, 2011

    Report

    Report Number
    3006630150-2011-00234
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 29, 2011
    Report Date
    January 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE PADDLE LEAD AND IPG REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE PADDLE LEAD AND IPG FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT THE PT WAS IN SURGERY FOR A POSSIBLE INFECTION AT THE MIDLINE CERVICAL INCISION DUE TO SWELLING. AFTER LEAVING THE HOSPITAL THE PT CONTACTED THE BSN SALES REP BECAUSE HE WAS CONCERNED ABOUT BLEEDING FROM THE INCISION SITE. THE PHYSICIAN DID NOT FEEL THE PT 'S POSSIBLE INFECTION WAS DEVICE OR PROCEDURE RELATED AND HE DID NOT HAVE A BLEEDING ISSUE. THE PHYSICIAN IRRIGATED THE POCKET.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS IN SURGERY FOR A POSSIBLE INFECTION AT THE MIDLINE CERVICAL INCISION DUE TO SWELLING. AFTER LEAVING THE HOSPITAL THE PATIENT CONTACTED THE BSN SALES REPRESENTATIVE BECAUSE HE WAS CONCERNED ABOUT BLEEDING FROM THE INCISION SITE. THE PHYSICIAN DID NOT FEEL THE PATIENT'S POSSIBLE INFECTION WAS DEVICE OR PROCEDURE RELATED AND HE DID NOT HAVE A BLEEDING ISSUE. THE PHYSICIAN IRRIGATED THE POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention MODEL # SC-1110-02, (B)(4)| IPG KIT (WITHOUT PULL-THROUGH TUNNELER)