BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2151870 · Received July 6, 2011

    Report

    Report Number
    3006630150-2011-01012
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 11, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2218-50, (B)(4), DESCRIPTION: ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014 INCH STYLET MODEL # SC-1110-02, (B)(4), DESCRIPTION: IPG KIT (WITHOUT PULL-THROUGH TUNNELER) THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INDICATED THAT THE IPG PASSED VISUAL AND PERFORMANCE TESTS. DAMAGES TO THE LEADS WERE A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT WAS NOT CONSIDERED A FAILURE.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE EXPLANTED DEVICES FOUND THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A REVIEW OF THE STERILIZATION RECORDS OF THE EXPLANTED DEVICES FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO INFECTION AT THE MIDLINE INCISION SITE. THE PATIENT'S SYMPTOMS INCLUDED FEVER, REDNESS, AND PAIN AT THE INCISION SITE. THE PHYSICIAN BELIEVES THE INFECTION WAS 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 INFECTION AT THE MIDLINE INCISION SITE. THE PATIENT'S SYMPTOMS INCLUDED FEVER, REDNESS, AND PAIN AT THE INCISION SITE. THE PHYSICIAN BELIEVES THE INFECTION WAS 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 INFECTION AT THE MIDLINE INCISION SITE. THE PATIENT'S SYMPTOMS INCLUDED FEVER, REDNESS, AND PAIN AT THE INCISION SITE. THE PHYSICIAN BELIEVES THE INFECTION WAS 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-2218-50 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R