BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3914496 · Received July 3, 2014

    Report

    Report Number
    3006630150-2014-01527
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD INFECTION AFTER PROCEDURE WAS DONE. THE INFECTION DID NOT OCCUR BEFORE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A RECENTLY IMPLANTED PATIENT WAS SUSPECTED OF HAVING AN INFECTION. THE IPG SITE WAS RED WITH LITTLE PUS. THE PHYSICIAN BELIEVED THAT THE SUSPECTED INFECTION WAS NOT DEVICE RELATED. THE PATIENT WAS PRESCRIBED KEFLEX ANTIBIOTICS AND WAS CLEARED FOR INFECTION.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A RECENTLY IMPLANTED PATIENT WAS SUSPECTED OF HAVING AN INFECTION. THE IPG SITE WAS RED WITH LITTLE PUS. THE PHYSICIAN BELIEVED THAT THE SUSPECTED INFECTION WAS NOT DEVICE RELATED. THE PATIENT WAS PRESCRIBED KEFLEX ANTIBIOTICS AND WAS CLEARED FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389751 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention