BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2093987 · Received May 13, 2011

    Report

    Report Number
    3007566237-2011-03511
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    November 4, 2010
    Report Date
    April 12, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. THE PATIENT INFORMATION PROVIDED IN SECTION A IS THE AVERAGE FOR ALL THE PATIENTS. AT THIS TIME, NO ADDITIONAL INFORMATION WAS AVAILABLE, ADDITIONAL INFORMATION REGARDING THE PATIENT, EVENT AND OUTCOME HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: TOMYCZ ND, DEIBERT CP, MOOSSY JJ. CERVICOMEDULLARY JUNCTION SPINAL CORD STIMULATION FOR HEAD AND FACIAL PAIN. HEADACHE: THE JOURNAL OF HEAD AND FACE PAIN. 2011;51(3):418-425. SUMMARY: THE AUTHORS REPORT ON PATIENTS WITH CERVICOMEDULLARY JUNCTION SPINAL CORD STIMULATION (SCS), TO ALLEVIATE INTRACTABLE HEAD AND FACIAL PAIN. AN ELECTRONIC SEARCH OF MEDICAL RECORDS FROM 1990 TO 2009 IDENTIFIED 35 PATIENTS (9 MEN, 26 WOMEN) WHO WERE TRIALED WITH PADDLE LEAD CERVICOMEDULLARY JUNCTION STIMULATION (CMJ-S). TWENTY-FIVE PATIENTS HAD A SUCCESSFUL TRIAL WITH SUBSEQUENT IMPLANTATION OF SCS HARDWARE. FOLLOW-UP VIA STRUCTURED TELEPHONE INTERVIEW WAS OBTAINED IN 16 OF THE PATIENTS THAT WERE IMPLANTED. THE MEAN PATIENT AGE WAS 47.3 YEARS OLD. OVERALL, PAIN INTENSITY DROPPED FROM 9.6 TO 4.8 (10 BEING THE WORST PAIN) AT FOLLOW-UP. REPORTABLE EVENTS: IT WAS REPORTED THAT ONE PATIENT EXPERIENCED AN INFECTION THAT REQUIRED COMPLETE REMOVAL OF ALL SCS HARDWARE; ONE PATIENT EXPERIENCED UNCOMFORTABLE PARESTHESIAS THAT WERE ATTRIBUTED TO A BREAKDOWN OF CONNECTING WIRE INSULATION DISCOVERED INTRAOPERATIVELY AND THREE PATIENTS EXPERIENCED A GRADUAL LOSS OF EFFECTIVENESS THAT PROMPTED HARDWARE EXPLANTATION WHICH COULD NOT BE EXPLAINED BY LEAD MIGRATION OR OTHER HARDWARE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention