BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2173447 · Received July 23, 2011

    Report

    Report Number
    3006630150-2011-01088
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-8216-50 SERIAL # (B)(4) DESCRIPTION: ARTISAN 2X8 PADDLE LEAD (LIM), 50 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 EXPLANTED DUE TO AN INFECTION AT THE IPG SITE AND THE MIDLINE INCISION SITE. THE PATIENT'S SYMPTOMS INCLUDED TENDERNESS AT BOTH SITES AND A HIGH FEVER. THE PHYSICIAN IS UNSURE IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS AND WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO AN INFECTION AT THE IPG SITE AND THE MIDLINE INCISION SITE. THE PATIENT'S SYMPTOMS INCLUDED TENDERNESS AT BOTH SITES AND A HIGH FEVER. THE PHYSICIAN IS UNSURE IF THE INFECTION WAS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS AND WAS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| R