BEUDAMED
    FDA Adverse Event Summary report: N

    PRECISION

    MDR report key: 1834091 · Received September 7, 2010

    Report

    Report Number
    3006630150-2010-01501
    Date Received
    September 7, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 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 Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE AS IF THE DEVICE WAS RUBBING ON THE PATIENT'S RIBS AND HIP. THE PATIENT ALSO REPORTED THAT THE LEADS FELT SUPERFICIAL. A POCKET REVISION WAS RECOMMENDED BY THE PHYSICIAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention