BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA®

    MDR report key: 3990650 · Received August 8, 2014

    Report

    Report Number
    3006630150-2014-01805
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    October 24, 2012
    Report Date
    June 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS ALSO EXPERIENCING SHOCKING SENSATIONS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#: SC-2218-50, SERIAL #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 50CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING BURNING SENSATION AND PAIN AT THE LEAD SITE. DATABASE ANALYSIS CONFIRMED HIGH IMPEDANCES ON SEVERAL CONTACTS AND THAT THE DEVICE WAS WORKING AS EXPECTED. THE PATIENT UNDERWENT AN EXPLANT WHEREIN SOME CONTACTS CAME OFF LOOSE DURING THE PROCEDURE BUT NO SINGLE CONTACT WAS DISLODGED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING BURNING SENSATION AND PAIN AT THE LEAD SITE. DATABASE ANALYSIS CONFIRMED HIGH IMPEDANCES ON SEVERAL CONTACTS AND THAT THE DEVICE WAS WORKING AS EXPECTED. THE PATIENT UNDERWENT AN EXPLANT WHEREIN SOME CONTACTS CAME OFF LOOSE DURING THE PROCEDURE BUT NO SINGLE CONTACT WAS DISLODGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467724 PRECISION SPECTRA® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention