BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2891886 · Received December 31, 2012

    Report

    Report Number
    3006630150-2012-02444
    Event Type
    Injury
    Date Received
    December 31, 2012
    Date of Event
    June 28, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE DUE TO POCKET PAIN. THE PATIENT EXPERIENCED POCKET SITE IRRITATION IN WHICH THE PHYSICIAN BELIEVED IT TO BE DUE TO SLOW AND IMPROPER WOUND HEALING FROM THE TIME IT WAS IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention