BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3873514 · Received June 14, 2014

    Report

    Report Number
    3006630150-2014-01323
    Event Type
    Injury
    Date Received
    June 14, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL #:  SC-2218-70 SERIAL #: (B)(4), DESCRIPTION:LINEAR ST LEAD, 70CM

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. DEVICE MALFUNCTION WAS NOT SUSPECTED. THE DEVICE DID NOT CAUSE THE WORSENING OF PAIN. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT FELT MORE PAIN WHEN HE HAS THE STIMULATION. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT FELT MORE PAIN WHEN HE HAS THE STIMULATION. THE PATIENT WILL UNDERGO AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351910 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention