BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEU_INTERSTIM_INS

    MDR report key: 6804229 · Received August 18, 2017

    Report

    Report Number
    3007566237-2017-03365
    Event Type
    Malfunction
    Date Received
    August 18, 2017
    Date of Event
    June 13, 2017
    Report Date
    October 19, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE.A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    (B)(4), REAL-TIME CHANGES IN BRAIN ACTIVITY DURING SACRAL NEUROMODULATION FOR OVERACTIVE BLADDER. THE JOURNAL OF UROLOGY. 2017. (B)(4) DOI: (B)(6).2017.06.074 SUMMARY: TO USE FUNCTIONAL MAGNETIC RESONANCE IMAGING(FMRI) FOR IDENTIFYING CHANGES IN BRAIN ACTIVITY DURING SACRAL NEUROMODULATION(SNM) IN WOMEN WITH OVERACTIVE BLADDER(OAB) WHO WERE RESPONSIVE TO THERAPY. WOMEN WITH NON-NEUROGENIC REFRACTORY OAB WHO RESPONDED TO SNM, HAD A STABLE PROGRAM FOR AT LEAST 3 MONTHS, WITH NO SUBSEQUENT OAB TREATMENT WERE RECRUITED. ENROLLED PATIENTS COMPLETED PRE-FMRI VALIDATED SYMPTOM AND QUALITY OF LIFE INSTRUMENTS. STIMULUS SETTINGS WERE RECORDED, DEVICES SWITCHED OFF (5-DAY WASHOUT), AND INSTRUMENTS REPEATED. THREE FMRI SCANS WITH SIMULTANEOUS SNM STIMULATION WERE PERFORMED BELOW, AT, AND ABOVE STIMULUS SENSORY THRESHOLD, USING A BLOCK DESIGN, YIELDING BRAIN ACTIVITY MAPS REPRESENTED BY CHANGES IN BLOOD OXYGENATION LEVEL DEPENDENCE(BOLD). A TOTAL OF 5 STIMULATOR-OFF AND 4 STIMULATOR-ON CYCLES OF 42 SECONDS EACH WERE IMAGED. A GROUP ANALYSIS USED A SINGLE VOXEL P-VALUE 0.05 WITH FALSE POSITIVE ERROR OF 0.05 (CLUSTER-ANALYSIS DETERMINED). RESULTS: OF 13 PATIENTS ENROLLED, 6 COMPLETED FMRI AND HAD A MEDIAN AGE OF (B)(6). URINARY SYMPTOMS AND VOIDING DIARY DATA WORSENED WITH WASHOUT. OVERALL, BRAIN ACTIVATION GENERALLY PROGRESSED WITH INCREASING STIMULATION AMPLITUDE, BUT ACTIVATION OF THE RIGHT INFERIOR FRONTAL GYRUS REMAINED STABLE, WHILE DEACTIVATION OF THE PONS AND PERIACQUEDUCTAL GRAY MATTER ONLY OCCURRED WITH SUB-SENSORY SIMULATION. SENSORY STIMULATION ACTIVATED INSULA BUT DEACTIVATED THE MEDIAL AND SUPERIOR PARIETAL LOBES. SUPRASENSORY STIMULATION ACTIVATED MULTIPLE STRUCTURES AND THE EXPECTED S3 SOMATOSENSORY REGION. ALL DEVICES HAD NORMAL IMPEDANCES AFTER FMRI. FMRI CONFIRMS SNM INFLUENCES BRAIN ACTIVITY IN WOMEN WITH OAB WHO RESPONDED TO THERAPY. THESE CHANGES VARY WITH STIMULUS INTENSITY. REPORTED EVENTS: 1. ONE PATIENT REPORTED THAT THEY EXPERIENCED LEG PAIN DURING THE SCAN AND WAS REPORTED AS AN ADVERSE EVENT. THE PATIENT¿S PAIN RESOLVED IMMEDIATELY UPON CESSATION OF THE FMRI SEQUENCE WITH NO ILL EFFECTS AT 1 AND 2 MONTHS POST-IMAGING, NOR UPON DEVICE INTERROGATION. PER THE MRI RADIOLOGIST THEY THOUGHT THE PATIENT WAS SUPER SENSITIVE TO THE MAGNETIC FIELD AND THAT THE LEG PAIN REPRESENTED MUSCLE STIMULATION WHICH WAS UNRELATED TO THE DEVICE. NO PATIENT HARM WAS INDICATED.

    Description of Event or Problem · 1

    GILL, B. C., PIZARRO-BERDICHEVSKY, J., BHATTACHARYYA, P. K., BRINK, T. S., MARKS, B. K., QUIROUET, A., VASAVADA, S. P., JONES, S. E., GOLDMAN, H. B. REAL-TIME CHANGES IN BRAIN ACTIVITY DURING SACRAL NEUROMODULATION FOR OVERACTIVE BLADDER. THE JOURNAL OF UROLOGY. 2017. S0022-5347(17)74951-8 DOI: 10.1016/J.JURO.2017.06.074. SUMMARY: TO USE FUNCTIONAL MAGNETIC RESONANCE IMAGING(FMRI) FOR IDENTIFYING CHANGES IN BRAIN ACTIVITY DURING SACRAL NEUROMODULATION(SNM) IN WOMEN WITH OVERACTIVE BLADDER(OAB) WHO WERE RESPONSIVE TO THERAPY. WOMEN WITH NON-NEUROGENIC REFRACTORY OAB WHO RESPONDED TO SNM, HAD A STABLE PROGRAM FOR AT LEAST 3 MONTHS, WITH NO SUBSEQUENT OAB TREATMENT WERE RECRUITED. ENROLLED PATIENTS COMPLETED PRE-FMRI VALIDATED SYMPTOM AND QUALITY OF LIFE INSTRUMENTS. STIMULUS SETTINGS WERE RECORDED, DEVICES SWITCHED OFF (5-DAY WASHOUT), AND INSTRUMENTS REPEATED. THREE FMRI SCANS WITH SIMULTANEOUS SNM STIMULATION WERE PERFORMED BELOW, AT, AND ABOVE STIMULUS SENSORY THRESHOLD, USING A BLOCK DESIGN, YIELDING BRAIN ACTIVITY MAPS REPRESENTED BY CHANGES IN BLOOD OXYGENATION LEVEL DEPENDENCE(BOLD). A TOTAL OF 5 STIMULATOR-OFF AND 4 STIMULATOR-ON CYCLES OF 42 SECONDS EACH WERE IMAGED. A GROUP ANALYSIS USED A SINGLE VOXEL P-VALUE 0.05 WITH FALSE POSITIVE ERROR OF 0.05 (CLUSTER-ANALYSIS DETERMINED). RESULTS: OF 13 PATIENTS ENROLLED, 6 COMPLETED FMRI AND HAD A MEDIAN AGE OF 52 [36-64] YEARS. URINARY SYMPTOMS AND VOIDING DIARY DATA WORSENED WITH WASHOUT. OVERALL, BRAIN ACTIVATION GENERALLY PROGRESSED WITH INCREASING STIMULATION AMPLITUDE, BUT ACTIVATION OF THE RIGHT INFERIOR FRONTAL GYRUS REMAINED STABLE, WHILE DEACTIVATION OF THE PONS AND PERIACQUEDUCTAL GRAY MATTER ONLY OCCURRED WITH SUB-SENSORY S8MULA8ON. SENSORY STIMULATION ACTIVATED INSULA BUT DEACTIVATED THE MEDIAL AND SUPERIOR PARIETAL LOBES. SUPRASENSORY STIMULATION ACTIVATED MULTIPLE STRUCTURES AND THE EXPECTED S3 SOMATOSENSORY REGION. ALL DEVICES HAD NORMAL IMPEDANCES AFTER FMRI. FMRI CONFIRMS SNM INFLUENCES BRAIN ACTIVITY IN WOMEN WITH OAB WHO RESPONDED TO THERAPY. THESE CHANGES VARY WITH STIMULUS INTENSITY. REPORTED EVENTS: PLI 10: ONE PATIENT REPORTED THAT THEY EXPERIENCED LEG PAIN DURING THE SCAN AND WAS REPORTED AS AN ADVERSE EVENT. THE PATIENT¿S PAIN RESOLVED IMMEDIATELY UPON CESSATION OF THE FMRI SEQUENCE WITH NO ILL EFFECTS AT 1 AND 2 MONTHS POST-IMAGING, NOR UPON DEVICE INTERROGATION. THIS PATIENT WAS EXTREMELY SENSITIVE TO STIMULUS AMPLITUDES DURING PROGRAMMING. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585340 NEU_INTERSTIM_INS INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1