BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3882381 · Received June 18, 2014

    Report

    Report Number
    3006630150-2014-01380
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT¿S MIDLINE INCISION WAS NOT HEALING PROPERLY AND THE INCISION HAD REOPENED. THE PHYSICIAN CLEANED OUT AND RE-SUTURED THE INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357482 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention