BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1961048 · Received January 11, 2011

    Report

    Report Number
    3006630150-2011-00008
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL # SC-2218-50E (B)(4) DESCRIPTION: ST LINEAR TRIAL LEAD, 50CM WITH PRE-LOADED 0.014 INCH STYLET (STREAMLINED) THE EXPLANTED LEADS ((B)(4)) WERE NOT RETURNED TO BSN AS THEY WERE KEPT BY THE MEDICAL FACILITY. IMPEDANCE READINGS ON LEAD ((B)(4)) WERE WITHIN NORMAL RANGE. ALL TESTS PERFORMED DEMONSTRATED THAT THE LEAD WAS MECHANICALLY FULLY INTACT AND PERFORMED AS EXPECTED. THE DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A TRIAL PROCEDURE, THE PATIENT REPORTED A HEADACHE. THE PHYSICIAN CONFIRMED A DURA PUNCTURE OCCURRED DURING THE TRIAL. THE PATIENT WAS PRESCRIBED PAIN MEDICATION AND WAS INSTRUCTED TO REST AND DRINK CAFFEINE. THE PATIENT REPORTED THAT SHE WAS FEELING BETTER.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A TRIAL PROCEDURE, THE PATIENT REPORTED A HEADACHE. THE PHYSICIAN CONFIRMED A DURA PUNCTURE OCCURRED DURING THE TRIAL. THE PATIENT WAS PRESCRIBED PAIN MEDICATION AND WAS INSTRUCTED TO REST AND DRINK CAFFEINE. THE PATIENT REPORTED THAT SHE WAS FEELING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50E NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention