BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 3823891 · Received May 21, 2014

    Report

    Report Number
    3006630150-2014-01123
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 24, 2014
    Report Date
    November 12, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S SYMPTOMS WERE PUS AND SWELLING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED AN INFECTION AT THE IPG SITE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS PROCEDURE RELATED. THE PATIENT WAS PRESCRIBED CLENDOMYCIN AND AUGMENTIN, AND HAD SWITCHED TO DRY DRESSINGS. THE PATIENT WAS REPORTEDLY DOING WELL AND THE INFECTION HAD CLEARED UP.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED AN INFECTION AT THE IPG SITE. THE PHYSICIAN BELIEVED THAT THE INFECTION WAS PROCEDURE RELATED. THE PATIENT WAS PRESCRIBED CLENDOMYCIN AND AUGMENTIN, AND HAD SWITCHED TO DRY DRESSINGS. THE PATIENT WAS REPORTEDLY DOING WELL AND THE INFECTION HAD CLEARED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302651 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 16633521

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention