BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3885094 · Received June 19, 2014

    Report

    Report Number
    3006630150-2014-01374
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT¿S DISCOMFORT WAS NOT CAUSED BY THE DEVICE/STIMULATION, BUT WAS A PRE-EXISTING CONDITION DUE TO LACK OF STIMULATION IN THE AREA.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2218-50 SERIAL #: (B)(4) DESCRIPTION: LINEAR ST LEAD, 50CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S LEADS HAD MIGRATED AS CONFIRMED BY X-RAY CAUSING DISCOMFORT. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S LEADS HAD MIGRATED AS CONFIRMED BY X-RAY CAUSING DISCOMFORT. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361342 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention| S