BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 10214545 · Received June 30, 2020

    Report

    Report Number
    2182207-2020-00448
    Event Type
    Injury
    Date Received
    June 30, 2020
    Date of Event
    March 23, 2020
    Report Date
    October 29, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 1

    ERDOGRU, T., ONUR, R. LAPAROSCOPIC SELECTIVE PUDENDAL NEUROMODULATION FOR NEUROGENIC BLADDER: A REVIEW OF LITERATURE. CENT EUROPEAN J UROL. 2020. 73(1):39-41. DOI: 10.5173/CEJU.2020.0036. SUMMARY: THIS STUDY PRESENTS AN ALTERNATIVE TECHNIQUE FOR NEUROMODULATION IN CASES WHERE PERCUTANEOUS SACRAL IMPLANTATION IS DIFFICULT OR HAS PREVIOUSLY FAILED. WE AIMED TO DESCRIBE A NOVEL TECHNIQUE OF SELECTIVE PLACEMENT OF AN ELECTRODE OVER THE PUDENDAL NERVE (PN), VIA LAPAROSCOPIC APPROACH IN A PATIENT WITH URINARY RETENTION WHO PREVIOUSLY FAILED SACRAL NEUROMODULATION (SNM) TREATMENT. REPORTED EVENT: A (B)(6) YEAR-OLD WOMAN WITH A TETHERED CORD PRESENTED WITH URINARY RETENTION. SHE WAS ON CLEAN INTERMITTENT SELF CATHETERIZATION (CIC) FOR THE LAST 18 YEARS. HER PREVIOUS HISTORY REVEALED CHRONIC URINARY TRACT INFECTIONS BEFORE THE START OF CIC. THE PATIENT RECEIVED SNM THERAPY IN 2017 BY IMPLANTING A PERMANENT ELECTRODE SNM THERAPY CONTINUED TO BE SUCCESSFUL FOR 5 MONTHS AFTER WHICH THE PATIENT REPORTED THE REOCCURRENCE OF URINARY RETENTION SYMPTOMS AND NEED FOR CIC AGAIN. SINCE PERCUTANEOUS SACRAL IMPLANTATION WAS IMPOSSIBLE TO REPEAT IN THE CONTRALATERAL SITE, THE PATIENT WAS HOSPITALIZED FOR AN ALTERNATIVE TECHNIQUE OF SELECTIVE PN NEUROMODULATION. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677463 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization