BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2031973 · Received March 28, 2011

    Report

    Report Number
    3006630150-2011-00426
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS EXPLANTED AND REPORTEDLY DOING FINE. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN FOR EVALUATION AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S POCKET SITE LOCATION WAS UNCOMFORTABLE AND HAD NOT USED THE SCS SYSTEM IN A WHILE. THE PHYSICIAN HAS AGREED TO EXPLANT THE PATIENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT'S POCKET SITE LOCATION WAS UNCOMFORTABLE AND HAD NOT USED THE SCS SYSTEM IN A WHILE. THE PHYSICIAN HAS AGREED TO EXPLANT THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention