BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZW

    MDR report key: 9192600 · Received October 15, 2019

    Report

    Report Number
    3007566237-2019-02128
    Event Type
    Injury
    Date Received
    October 15, 2019
    Date of Event
    July 20, 2019
    Report Date
    July 7, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D11: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. 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

    EVENT DATE: 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 SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID: NEU_INS_STIMULATOR LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID: NEU_INS_STIMULATOR, LOT# UNKNOWN , PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DE OLIVEIRA, P. S., REIS, J. P., DE OLIVEIRA, T. R., MARTINHO, D., SILVA, R. P. E., MARCELINO, J., GASPAR, S., MARTINS, F., LOPES, T. THE IMPACT OF SACRAL NEUROMODULATION ON SEXUAL DYSFUNCTION. CURRENT UROLOGY. 2018. 12(4):188-194. DOI: 10.1159/000499307. SUMMARY: SACRAL NEUROMODULATION (SNM) IS A WELL-ESTABLISHED TREATMENT IN SEVERAL URINARY AND BOWEL DYSFUNCTIONS, NEVERTHELESS ITS ROLE ON SEXUAL DYSFUNCTION REMAINS UNCLEAR. WE EVALUATE THE IMPACT OF SNM ON SEXUAL FUNCTION AND ITS ASSOCIATION WITH AGE AT SNM, FUNCTIONAL DIAGNOSIS AND POST-VOID RESIDUAL URINE (PVR) BEFORE SNM. PATIENTS WHO HAD SNM WERE RETROSPECTIVELY ANALYZED. SEXUAL FUNCTION WAS ASSESSED BEFORE AND AFTER TREATMENT WITH THE INTERNATIONAL INDEX OF ERECTILE FUNCTION (IIEF-5) FOR MEN AND THE FEMALE SEXUAL FUNCTION INDEX (FSFI) FOR WOMEN. IIEF-5 AND FSFI WERE ALSO ASSOCIATED WITH AGE ATSNM, FUNCTIONAL DIAGNOSIS, AND PVR. FIFTEEN FEMALES AND 9 MALES, WITH A MEDIAN AGE OF 41 YEARS (26¿72 YEARS) , MEDIAN FOLLOW-UP 20.7 MONTHS (2¿53 MONTHS) WERE ENROLLED. IIEF-5 IMPROVED IN 4 PATIENTS (P = 0.06), AND FSFI TOTAL SCOREIN 5 (P = 0.2). THERE WAS SIGNIFICANT ASSOCIATION BETWEEN FUNCTIONAL DIAGNOSIS AND FSFI TOTAL SCORE (P = 0.05), AND FSFI SPECIFIC DOMAINS OF AROUSAL (P = 0.03), LUBRICATION (P = 0.04),AND SATISFACTION (P = 0.03), WITH SIGNIFICANT IMPROVEMENT SHOWED IN PATIENTS WITH DETRUSOR OVERACTIVITY WITH IMPAIRED CONTRACTILITY. ALTHOUGH GAINS OBSERVED IN IIEF-5 AND FSFI WERE MODEST, OUR PRELIMINARY RESULTS SHOW THAT SNM MAY HAVE FAVORABLE IMPACT ON SEXUAL FUNCTION. REPORTED EVENTS: IN THE STUDY, ADVERSE EVENTS WERE MOSTLY MINOR WITH ONLY 4 PATIENTS (16.7%) REQUIRING SURGICAL REVISION. THE REMAINING ADVERSE EVENTS WERE DEALT WITH REPROGRAMMING. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988813 EZW INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention "SEE H10...."