BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2181704 · Received July 27, 2011

    Report

    Report Number
    3006630150-2011-01161
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 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

    THE EXPLANTED IPG PASSED VISUAL AND PERFORMANCE TESTS DONE. THE DEVICE EXHIBITS NORMAL DEVICE CHARACTERISTICS. VISUAL INSPECTION OF THE EXPLANTED LEADS REVEALED DAMAGES DONE TO THE LEADS IS A RESULT OF A TYPICAL EXPLANT PROCEDURE AND IT IS NOT CONSIDERED A FAILURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL#:SC-2218-50, (B)(4) & (B)(4), DESCRIPTION: ENH ST LD KIT, 50 CM. THE EXPLANTED LEADS WILL NOT BE 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 ABCESS. THE LOCATION IS UNKNOWN. THE PHYSICIAN DOES NOT BELIEVE THAT THE ABCESS WAS DEVICE OR PROCEDURE RELATED AND NO FURTHER INFORMATION WAS PROVIDED TO BSN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPLANTED DUE TO AN ABCESS. THE LOCATION IS UNKNOWN. THE PHYSICIAN DOES NOT BELIEVE THAT THE ABCESS WAS DEVICE OR PROCEDURE RELATED AND NO FURTHER INFORMATION WAS PROVIDED TO BSN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R