BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 8616009 · Received May 16, 2019

    Report

    Report Number
    3007566237-2019-01080
    Event Type
    Injury
    Date Received
    May 16, 2019
    Date of Event
    July 26, 2018
    Report Date
    June 24, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL# PRODUCT TYPE LEAD PRODUCT ID 3625 LOT# UNKNOWN SERIAL# PRODUCT TYPE SCREENING DEVICE PRODUCT ID 3058 LOT# UNKNOWN SERIAL# PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3058 LOT# UNKNOWN SERIAL# PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3625 LOT# UNKNOWN SERIAL# PRODUCT TYPE SCREENING DEVICE PRODUCT ID 3625 LOT# UNKNOWN SERIAL# PRODUCT TYPE SCREENING DEVICE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: 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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT #: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 3625, LOT #: UNKNOWN, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: 3058, LOT #: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3058, LOT #: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3625, LOT #: UNKNOWN, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: 3625, LOT #: UNKNOWN, PRODUCT TYPE: SCREENING DEVICE. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 3625, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 3058, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 3625, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    YIANNAKOU, Y., ETHERSON, K., CLOSE, H., KASIM, A., MERCER-JONES, M., PLUSA, S., MAIER, R., GREEN, S., CUNDALL, J., KNOWLES, C., MASON, J. A. "RANDOMIZED DOUBLE-BLINDED SHAM-CONTROLLED CROSS-OVER TRIAL OF TINED-LEAD SACRAL NERVE STIMULATION TESTING FOR CHRONIC CONSTIPATION." EUR J GASTROENTEROL HEPATOL. 2019. 31(6): 653-660. DOI: 10.1097/MEG.0000000000001379. SUMMARY: SACRAL NERVE STIMULATION (SNS) MAY PROVIDE LONG-TERM SYMPTOM RELIEF TO PATIENTS SUFFERING FROM CHRONIC CONSTIPATION. PATIENTS ARE CURRENTLY SELECTED FOR SNS USING A 2-WEEK PERIPHERAL NERVE EVALUATION (PNE) COMPRISING STIMULATION BY TEMPORARY LEADS. HOWEVER, ONLY 40% OF TEST RESPONDERS RECEIVE LONG-TERM BENEFIT FROM TREATMENT MEANING THAT HEALTHCARE COSTS PER SUCCESSFULLY TREATED PATIENT ARE TOO HIGH. THE PRIMARY OBJECTIVE WAS TO ASSESS TINED-LEAD TESTING TO PREDICT BENEFIT FROM SNS FOR CHRONIC CONSTIPATION. PATIENTS AND METHODS A RANDOMIZED DOUBLE-BLIND SHAM-CONTROLLED CROSS-OVER DESIGN EVALUATED ENHANCED PNE (EPNE) USING TINED QUADRIPOLAR ELECTRODE LEADS OVER 6 WEEKS. THE DESIGN DIFFERENTIATED BETWEEN PATIENTS WITH DISCRIMINATE AND INDISCRIMINATE RESPONSES TO TESTING. A SCORE IMPROVEMENT OF 25% OR MORE WAS CONSIDERED TO BE A POSITIVE RESPONSE WITHIN A STIMULATION PERIOD. THE PRIMARY OUTCOME WAS THE PROPORTION OF PATIENTS SHOWING A REDUCTION OF AT LEAST 0.5 IN CONSTIPATION SYMPTOM SCORE AT 6 MONTHS. A TOTAL OF 45 PATIENTS WERE RANDOMIZED, OF WHOM 29 (64.4%) WERE TEST-PHASE RESPONDERS. OF THESE, 27 WERE IMPLANTED PROVIDING PERMANENT SNS. DURING EPNE, SEVEN (18%) WERE DISCRIMINATE RESPONDERS, 22 (56%) WERE INDISCRIMINATE RESPONDERS AND 10 (26%) WERE NONRESPONDERS. SIX PATIENTS WERE WITHDRAWN DURING THE TEST PHASE BECAUSE OF INFECTION OR NONCOMPLIANCE. AT 6 MONTHS, THERE WAS NO SIGNIFICANT DIFFERENCE IN PRIMARY OUTCOME BETWEEN DISCRIMINATE AND INDISCRIMINATE RESPONDERS (60 VS. 57%, P= 0.76). THE STUDY WAS TERMINATED PREMATURELY BECAUSE OF A PERSISTENT INFECTION RATE OF 10 (22%) DURING EPNE OF WHICH NINE (20%) WERE SEVERE. EPNE IS A POOR PREDICTOR OF TREATMENT RESPONSE AT 6 MONTHS. THIS SUGGESTS A STRONG AND PERSISTENT PLACEBO RESPONSE DURING BOTH SNS PNE AND TREATMENT. AN EXTENDED 6-WEEK PNE POSES A HIGH RISK OF INFECTION. REPORTED EVENTS: 6 PATIENTS EXPERIENCED A LEAD SITE INFECTION DURING THE TRIAL. OF THE THREE INFECTIONS AFFECTING THOSE WITH IPGS, ALL WERE LATE (>4 MONTHS FOLLOWING IMPLANTATION) WITH ONE IDENTIFIED AT THE 6-MONTH FOLLOW-UP. CHANGES IN SURGICAL PRACTICE FAILED TO REDUCE THE INFECTION RATE. THE ONE SUPERFICIAL INFECTION RESPONDED TO TREATMENT DURING THE TESTING PHASE. 11 PATIENTS EXPERIENCED A SEVERE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410790 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention