BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 4053211 · Received September 3, 2014

    Report

    Report Number
    3006630150-2014-01977
    Event Type
    Injury
    Date Received
    September 3, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 7, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-2158-50 SERIAL #: (B)(4) DESCRIPTION: LINEAR LEAD WITH ENHANCED STYLET, 50CM THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. A REVIEW OF THE STERILIZATION DOCUMENTATION FOR THE EXPLANTED DEVICES FOUND THEM TO BE SATISFACTORY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD NECROSIS AT THE EDGE OF THE POCKET SITE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE SINCE IT HAD BROKEN THROUGH THE SKIN DUE TO INFECTION. THE PHYSICIAN WAS NOT SURE IF THE NECROSIS WAS DEVICE RELATED BUT DID NOT BELIEVE THAT THE INFECTION WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539104 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention