BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3830417 · Received May 23, 2014

    Report

    Report Number
    3006630150-2014-01165
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 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

    THE EXPLANTED LEAD WAS NOT RETURNED TO BSN AS IT WAS DISCARDED BY THE MEDICAL FACILITY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN DID NOT BELIEVE THAT THE INFECTION WAS DEVICE OR PROCEDURE RELATED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED AN INFECTION. THE SUTURE IN THE CERVICAL INCISION SITE CAME LOOSE AND WAS OPENED LIFTING THE CERVICAL LEAD. PURULENT DISCHARGES WERE ALSO NOTED. THE PHYSICIAN REMOVED THE LEAD. ANTIBIOTICS WERE PRESCRIBED. THE PATIENT WAS DOING WELL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD DEVELOPED AN INFECTION. THE SUTURE IN THE CERVICAL INCISION SITE CAME LOOSE AND WAS OPENED LIFTING THE CERVICAL LEAD. PURULENT DISCHARGES WERE ALSO NOTED. THE PHYSICIAN REMOVED THE LEAD. ANTIBIOTICS WERE PRESCRIBED. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307586 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention