BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 4177960 · Received October 16, 2014

    Report

    Report Number
    3007566237-2014-03005
    Event Type
    Malfunction
    Date Received
    October 16, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT PRODUCT: PRODUCT ID 3057, LOT# UNKNOWN, PRODUCT TYPE SCREENING DEVICE. (B)(4).

    Description of Event or Problem · 1

    SHALOM, D.F., PILLALAMARRI, N., XUE, X., KOHN, N., LIND, L.R., WINKLER, H.A., METZ, C.N. SACRAL NERVE STIMULATION REDUCES ELEVATED URINARY NERVE GROWTH FACTOR LEVELS IN WOMEN WITH SYMPTOMATIC DETRUSOR OVERACTIVITY. AM. J. OBSTET. GYNECOL. 0002;2014 JUL 11. DOI: 10.1016/J.AJOG.2014.07.007 SUMMARY: TO INVESTIGATE CHANGES IN URINARY NERVE GROWTH FACTOR (UNGF) IN WOMEN WITH SYMPTOMATIC DETRUSOR OVERACTIVITY (DO) FOLLOWING PERIPHERAL NERVE EVALUATION (PNE) FOR SACRAL NEUROMODULATION VS CONTROLS. THERE WERE 23 SUBJECTS WITH OVERACTIVE BLADDER SYMPTOMS AND DO WHO FAILED MANAGEMENT WITH ANTICHOLINERGICS AND 22 CONTROLS CONSENTED TO PARTICIPATE IN THIS PROSPECTIVE PILOT STUDY. URINE SPECIMENS WERE COLLECTED FROM CONTROLS AT BASELINE FOR EVALUATION OF UNGF AND CREATININE. SUBJECTS WERE EVALUATED AT BASELINE AND 5 DAYS AFTER A TRIAL OF SACRAL NERVE STIMULATION REFERRED TO AS A PNE. EACH VISIT INCLUDED URINE COLLECTION FOR UNGF AND, INCONTINENCE QUALITY OF LIFE QUESTIONNAIRE, URINARY DISTRESS INVENTORY QUESTIONNAIRE, POSTVOID RESIDUAL VOLUME, AND A 3-DAY VOIDING DIARY. UNGF LEVELS WERE MEASURED BY ENZYME-LINKED IMMUNOSORBENT ASSAY AND EXPRESSED AS UNGF PG/CREATININE MG. SUBJECTS WITH DO HAD SIGNIFICANTLY HIGHER BASELINE UNGF LEVELS (CORRECTED FOR CREATININE) COMPARED WITH CONTROLS (19.82 PG/MG VS 7.88 PG/MG, P <(><<)> .002). SEVENTEEN DO SUBJECTS UNDERWENT PNE AND WERE EVALUATED AT THE END OF THE TESTING PERIOD. THERE WAS A SIGNIFICANT IMPROVEMENT IN QUALITY OF LIFE SCORES FOR SUBJECTS AFTER PNE COMPARED WITH BASELINE (URINARY DISTRESS INVENTORY QUESTIONNAIRE: 7.0 VS 13.7, P <(><<)> .001; INCONTINENCE QUALITY OF LIFE QUESTIONNAIRE: 87.3 VS 52.8, P <(><<)> .0001). CONCORDANTLY, UNGF LEVELS SIGNIFICANTLY DECREASED FROM 17.23 PG/MG TO 9.24 PG/MG (P <(><<)> .02) AFTER PNE. UNGF LEVELS DECREASE WITH SYMPTOMATIC RESPONSE IN DO SUBJECTS UNDERGOING PNE. DO SUBJECTS HAD SIGNIFICANTLY HIGHER UNGF AT BASELINE VS CONTROLS, AND UNGF LEVELS SIGNIFICANTLY DECREASED AFTER ONLY 5 DAYS OF SACRAL NERVE STIMULATION. THESE FINDINGS SUPPORT A LARGER STUDY TO VALIDATE THE USE OF UNGF AS AN OBJECTIVE TOOL TO ASSESS THERAPEUTIC OUTCOME IN PATIENTS UNDERGOING PNE FOR SACRAL NEUROMODULATION. REPORTED EVENT: ONE 84-YEAR-OLD FEMALE PATIENT EXPERIENCED LEAD DISPLACEMENT DURING THE PERIPHERAL NERVE EVALUATION (PNE). THE REPORTER STATED THAT THE LEAD DISPLACEMENT WAS DIAGNOSED IN PATIENTS WHO PERCEIVED STIMULATION IN AREAS OTHER THAN THE VAGINA, ANUS, AND PERINEUM, AND WAS CONFIRMED BY THE CLINICIAN WHO NOTED IMPROPER LOCATION OF A LEAD. IT WAS NOTED THAT THE PATIENT REPORTED ACCIDENTALLY PULLING THE LEAD AND NOTICING A SIGNIFICANT CHANGE IN SENSATION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO DEVICE MALFUNCTIONS OBSERVED IN THE OPERATING ROOM AND THE PATIENT FULLY RECOVERED FROM THE PNE. PLEASE NOTE THAT THIS EVENT WAS PREVIOUSLY REPORTED IN MANUFACTURING REPORT # 3007566237-2014-02383. DUE TO FOLLOW-UP INFORMATION RECEIVED CONTAINING PATIENT INFORMATION, ANY ADDITIONAL FOLLOW-UP INFORMATION RECEIVED WILL NOT BE REPORTED UNDER THE PREVIOUS MANUFACTURING REPORT NUMBER, BUT WILL BE REPORTED UNDER THIS NEW MANUFACTURING REPORT NUMBER. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: MODEL 3057 TEST STIMULATION LEAD AND MODEL 3625 EXTERNAL TEST STIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658413 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3625 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR