BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1885198 · Received October 25, 2010

    Report

    Report Number
    3006630150-2010-01821
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL BECAUSE ONE OF THE LEADS HAD MIGRATED INTO THE THORACIC AREA OF THE SPINE CAUSING CHEST PAIN. THE PATIENT'S PHYSICIAN REPOSITIONED THE LEAD AND THE PATIENT WAS REPORTEDLY DOING FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014" STYLET| MODEL#: SC-2218-50| SERIAL#: (B)(4)