BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4636283 · Received March 26, 2015

    Report

    Report Number
    3007566237-2015-00780
    Event Type
    Injury
    Date Received
    March 26, 2015
    Report Date
    March 5, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID 3058, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE. (B)(4).

    Description of Event or Problem · 1

    KASS-ILIYYA, A., JENKS, J., MOORE, C. M., HAMID, R., SHAH, J. R., GREENWELL, T. J., OCKRIM, J. L. TINED LEAD VERSUS PERCUTANEOUS NERVE EVALUATION FOR SACRAL NERVE STIMULATOR ASSESSMENT. JOURNAL OF CLINICAL UROLOGY. 2015 2015; 8(1):46-51. DOI: 10.1177/2051415814541651. SUMMARY: WE COMPARED THE OUTCOMES OF PERCUTANEOUS NERVE EVALUATION (PNE) WITH FIRST-STAGE TINED LEAD PLACEMENT (FSTLP) FOR THE TESTING PHASE OF SACRAL NERVE NEUROMODULATION (SNM), AND WE ASSESSED THE OUTCOMES OF THESE TWO TECHNIQUES FOLLOWING IMPLANTATION OF A (SECOND-STAGE) PERMANENT SACRAL NERVE STIMULATOR (SNS). SEVENTY CONSECUTIVE PATIENTS HAD EITHER PNE (N = 35) OR FSTLP (N = 35) EVALUATION, AND CONVERSION TO A PERMANENT SNS IMPLANT ACCORDING TO RESPONSE. PRIMARY OUTCOMES WERE ASSESSED USING FREQUENCY-VOLUME CHARTS, PAD TESTING, ICIQ/EQ5D QUESTIONNAIRES AND GLOBAL HEALTH PERCEPTION VISUAL ANALOGUE SCALE (VAS). SUCCESS WAS CONSIDERED IF THEY ACHIEVED GREATER THAN 50% IMPROVEMENT IN THEIR URINARY SYMPTOMS. SUCCESS AND FAILURE RATES WERE COMPARED DURING THE TEST PHASE AND AFTER IMPLANTATION OF THE SNS. MEAN FOLLOW-UP FOR THE FSTLP GROUP WAS 14 MONTHS (NINE TO 20) AND FOR THE PNE GROUP WAS 22 MONTHS (EIGHT TO 27). SIXTEEN (46%) OF THE PNE TESTS AND 20 (57%) OF THE FSTLP PATIENTS WERE CONVERTED TO PERMANENT IMPLANT. A SIGNIFICANT CORRELATION WAS NOTED BETWEEN PATIENTS¿ GENERAL HEALTH (VAS SCORE) AND A SUCCESSFUL TEST PHASE (R = 0.297, P = 0.013). EIGHTEEN OF 19 (95%) OF TINED LEAD PATIENTS HAVE SUCCESSFUL SNS IMPLANTS, WHEREAS FIVE OF 16 (31%) OF PNE EVALUATIONS FAILED TO CONVERT TEST EFFICACY TO THE PERMANENT SNS IMPLANT (P = 0.042). FURTHERMORE, TWO OF PNE-SNS PATIENTS WERE SUCCESSFULLY SALVAGED BY THE IMPLANTATION OF A SECOND TINED LEAD. FSTLP-SNS HAS A SIGNIFICANTLY HIGHER SUCCESS RATE THAN PNE-SNS IN CONVERTING THE TEST PHASE TO SNS IMPLANTATION. THIS MAY BE DUE IN PART TO DIFFICULTIES RETAINING ACCURATE LEAD PLACEMENT WITH THE TWO-LEAD (PNE-SNS) APPROACH. THESE FINDINGS HAVE IMPORTANT COST AND LOGISTICAL IMPLICATIONS FOR SNS SERVICES. REPORTED EVENT(S): 1. 1 PATIENT DEVELOPED AN INFECTION OF THE PERMANENT SACRAL NEUROMODULATION (SNM) IMPLANT AND REQUIRED EXPLANT DESPITE A SUCCESSFUL OUTCOME. THE PATIENT WAS REPORTEDLY AWAITING RE-IMPLANTATION AT A LATER DATE. 2. 1 PATIENT DEVELOPED AN INFECTION OF THE TINED LEAD DURING A SUCCESSFUL STAGE-1 TEST PHASE OF SNM. THE PATIENT WAS REPORTEDLY AWAITING RE-IMPLANTATION AT A LATER DATE. 3. 2 PATIENTS HAD FAILED PERMANENT IMPLANTS, DESPITE A SUCCESSFUL PERIPHERAL NERVE EVALUATION (PNE). IT WAS NOTED THAT THE PATIENTS WERE SUCCESSFULLY SALVAGED BY THE IMPLANTATION OF A SECOND TINED LEAD. 4. 3 PATIENTS HAD FAILED PERMANENT IMPLANTS, DESPITE A SUCCESSFUL PERIPHERAL NERVE EVALUATION (PNE). FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204216 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention