BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1903146 · Received November 17, 2010

    Report

    Report Number
    3006630150-2010-01915
    Event Type
    Injury
    Date Received
    November 17, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PT WAS EXPLANTED DUE TO INFECTION. THE PATIENT'S SYMPTOMS INCLUDED AN OPEN IPG SITE, PUS, REDNESS, AND SWELLING. THE PHYSICIAN REMOVED THE IPG AND IRRIGATED THE POCKET WITH ANTIBIOTIC SOLUTION. THE PT WAS GIVEN ORAL ANTIBIOTICS AND WAS 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 SC-1110-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention