BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1822712 · Received August 26, 2010

    Report

    Report Number
    3006630150-2010-01488
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT'S LEAD WAS EXHIBITING HIGH IMPEDANCES. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE, AND THE LEAD WAS REPLACED. THE PATIENT IS REPORTEDLY DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2138-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention