BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFY ENHANCED

    MDR report key: 15537163 · Received October 4, 2022

    Report

    Report Number
    2182207-2022-01852
    Event Type
    Malfunction
    Date Received
    October 4, 2022
    Date of Event
    May 19, 2022
    Report Date
    October 4, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ID NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UBD: UNKNOWN , UDI#: UNKNOWN B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. 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. 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.

    Description of Event or Problem · 0

    ELTERMAN D., MICHAELS J., MARGOLIS E., ET AL. PROSPECTIVE, MULTICENTER STUDY TO EVALUATE PERFORMANCE AND SAFETY OF A RE-ENGINEERED TEMPORARY LEAD FOR INTERSTIM¿ THERAPY EVALUATION. NEUROUROL URODYN. 2022;1-8. DOI:10.1002/NAU.24987 SUMMARY THE BASIC EVALUATION OR PERCUTANEOUS NERVE EVALUATION (PNE) IS A METHOD TO ASSESS PRE-IMPLANTATION THERAPEUTIC RESPONSE IN PATIENTS CONSIDERING SACRAL NEUROMODULATION FOR THE TREATMENT OF REFRACTORY OVERACTIVE BLADDER. A NEW PNE LEAD WITH A MORE ROBUST DESIGN AND GREATER DISTENSIBILITY DESIGNED TO REDUCE THE POSSIBILITY OF LEAD MIGRATION HAS RECENTLY BEEN INTRODUCED TO THE MARKET. THE AIM OF THIS PROSPECTIVE, MULTICENTER, GLOBAL, POSTMARKET STUDY WAS TO EVALUATE THE CLINICAL PERFORMANCE AND SAFETY OF THE NEW INTERSTIM PNE LEAD WITH THE FORAMEN NEEDLE. PATIENTS WITH OVERACTIVE BLADDER WERE ENROLLED IN THIS STUDY. THE PRIMARY OBJECTIVE OF THIS STUDY WAS TO DETERMINE THE PROPORTION OF SUBJECTS WHO DEMONSTRATED MOTOR OR SENSORY RESPONSE(S) DURING LEAD PLACEMENT USING THE INTERSTIM PNE LEAD. ADDITIONAL MEASURES INCLUDED THE PATIENT GLOBAL IMPRESSION OF IMPROVEMENT (PGI-I), PATIENT SATISFACTION AT THE END OF THERAPY EVALUATION, AND CHANGE IN BLADDER SYMPTOMS FROM BASELINE TO THE END OF THERAPY EVALUATION (1-WEEK FOLLOW-UP VISIT). ONE-HUNDRED AND TEN SUBJECTS MET THE INCLUSION AND EXCLUSION CRITERIA AND UNDERWENT A LEAD IMPLANT PROCEDURE. OF THOSE, 108 HAD A SUCCESSFUL PROCEDURE AND 107 COMPLETED THE 1-WEEK FOLLOW-UP VISIT. NINETYNINE PERCENT OF SUBJECTS (109/110) HAD A MOTOR OR SENSORY RESPONSE DURING NEEDLE PLACEMENT (95% CONFIDENCE INTERVAL [CI]: 95%¿100%) AND 97% OF SUBJECTS (107/110) HAD A MOTOR OR SENSORY RESPONSE DURING LEAD PLACEMENT (95% CI: 92%¿99%). THE MAJORITY OF SUBJECTS (88%, 95/108) REPORTED THEIR BLADDER CONDITION WAS BETTER AT THE FOLLOW-UP VISIT COMPARED TO BEFORE THE PNE IMPLANT PROCEDURE, AS REPORTED IN PGI-I. SUBJECTS REPORTED BEING SATISFIED WITH HOW THE THERAPY IMPACTED THEIR VOIDING SYMPTOMS (82%, 88/108) AND THAT THEY WOULD RECOMMEND THIS THERAPY (87%, 94/108) TO OTHER PATIENTS. SYMPTOM IMPROVEMENT WAS DEMONSTRATED WITH URINARY URGE INCONTINENCE SUBJECTS HAVING AN AVERAGE OF 4.2 ± 3.4 URINARY INCONTINENCE EPISODES/DAY AT BASELINE AND 2.2 ± 2.5 AT FOLLOW-UP, AND URINARY FREQUENCY SUBJECTS HAVING AN AVERAGE OF 12.5 ± 4.4 VOIDS/DAY AT BASELINE AND 10.5 ± 4.3 VOIDS/DAY AT FOLLOW-UP. LEAD REMOVAL WAS DEEMED TO BE EASY AND SAFE BY THE IMPLANTING PHYSICIAN, WITH A TOTAL OF THREE ADVERSE DEVICE EFFECTS IN 3/110 SUBJECTS. NO EVENT WAS CATEGORIZED AS SERIOUS AND ALL WERE RESOLVED WITHOUT SEQUELAE. THE UPDATED INTERSTIM PNE LEAD WITH A MORE ROBUST DESIGN AND GREATER DISTENSIBILITY DESIGNED TO REDUCE MIGRATION WAS SHOWN TO HAVE A HIGH RATE OF MOTOR OR SENSORY RESPONSE DURING LEAD PLACEMENT. FURTHERMORE, SUBJECTS REPORTED HIGH RATES OF GLOBAL IMPROVEMENTS AND AMELIORATION OF SYMPTOMS, AND THE LEAD WAS EASY TO REMOVE WITH MINIMAL MORBIDITY. REPORTED EVENTS: 1 PATIENTS LEAD WAS PARTIALLY DISLODGED DUE TO SKIN IRRITATION AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2387319 VERIFY ENHANCED STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION 353101

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown