BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3892521 · Received June 24, 2014

    Report

    Report Number
    3006630150-2014-01394
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 31, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD AN INFECTION AT THE POCKET SITE. SYMPTOMS WERE REDNESS AND SWELLING. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS NOT DEVICE OR PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368221 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention