BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2851779 · Received November 29, 2012

    Report

    Report Number
    3006630150-2012-02228
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE IPG AND LEADS WERE EXPLANTED AND REPLACED DUE TO PHYSICIAN'S PREFERENCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #: SC-1110-02, SERIAL #: (B)(4), DESCRIPTION: PRECISION IMPLANTABLE PULSE GENERATOR (IPG). THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE 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 MED WATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    CORRECTION TO INITIAL MDR FIELD: ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-3138-55 SERIAL #: (B)(4) DESCRIPTION: SCS PHIII EXT 55CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO EROSION. THE EROSION WAS DUE TO THE POCKET SITE BEING IMPLANTED IN A PREVIOUSLY INFECTED AREA (MFR REPORT# 3006630150-2012-01624).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO THE LEAD EXTENSION ERODED THROUGH THE SKIN. THE EROSION WAS DUE TO THE POCKET SITE BEING IMPLANTED IN A PREVIOUSLY INFECTED AREA (MFR REPORT# 3006630150-2012-01624).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO EROSION. THE EROSION WAS DUE TO THE POCKET SITE BEING IMPLANTED IN A PREVIOUSLY INFECTED AREA (MFR REPORT# 3006630150-2012-01624).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-3138-55 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R