BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 12018179 · Received June 17, 2021

    Report

    Report Number
    2182207-2021-01068
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    February 16, 2021
    Report Date
    September 13, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, EXPLANTED: 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THE THAT THE INFECTION WAS WRITTEN IN THE REPORT, BUT THE SKIN AT THE IMPLANTED PART BECAME THIN (THE IMPLANTED POSITION MIGHT BE NOT GOOD). THIS WAS A CASE THAT THE DEVICE WAS REMOVED BECAUSE ONE PART OF THE DEVICE BECAME VISIBLE. FROM IMPLANTATION TO REMOVAL, IT HAS BEEN MORE THAN HALF A YEAR, SO IT IS NOT A PERIOPERATIVE INFECTION.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_INS_STIMULATOR LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID NEU_INS_STIMULATOR LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID NEU_INS_STIMULATOR LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENOMOTO, H., NISHIZAWA, Y., INAMORI, K., HASEGAWA, H. IKEDA, K., TSUKADA, Y., SASAKI, T., ITO, M. SACRAL NEUROMODULATION FOR THE PRE VENTION OF A PERMANENT STOMA IN PATIENTS WITH SEVERE DEFECATION DISORDER FOLLOWING INTERSPHINCTERIC RESECTION. SURG TODAY. 2021. DOI: 10.1007/S00595-021-02233-5 SUMMARY: SEVERE DEFECATION DISORDER OCCURS FREQUENTLY IN COLOANAL ANASTOMOSIS FOR LOW RECTAL CANCER, AND MAY AFFECT QUALITY OF LIFE. SACRAL NEUROMODULATION (SNM) HAS BEEN REPORTED TO BE SUCCESSFUL AFTER RECTAL RESECTION, BUT THERE ARE NO RESULTS FOR PATIENTS TREATED WITH INTERSPHINCTERIC RESECTION (ISR). A RETROSPECTIVE SINGLE-CENTER STUDY OF SNM WAS PERFORMED FOR PATIENT WITH DEFECATION DISORDER FOLLOWING ISR. PRE- AND POST-TREATMENT BOWEL FREQUENCIES, FECAL INCONTINENCE EPISODES, AND WEXNER, LARS AND FIQL SCORES WERE ASSESSED TO EVALUATE THE EFFICACY. A GOOD RESPONSE WAS DEFINED AS = 50% REDUCTION OF BOWEL FREQUENCY PER DAY OR FECAL INCONTINENCE EPISODES PER WEEK. 10 PATIENTS (7 MALES, MEAN AGE 67.5 YEARS) UNDERWENT SNM. ALL PATIENTS HAD SEVERE FECAL INCONTINENCE WITH A MEDIAN WEXNER SCORE OF 15 (13¿20) AND A MEDIAN LARS SCORE OF 41 (36¿41). THE WEXNER SCORE IMPROVED AFTER SNM, BUT NOT SIGNIFICANTLY (P = 0.06). LARS AND FIQL SCORES SIGNIFICANTLY IMPROVED AFTER SNM (P = 0.02, P = 0.01). AT THE END OF FOLLOW-UP, THE GOOD RESPONSE RATE WAS 40%. THREE CASES WITHOUT A GOOD RESPONSE REQUIRED CREATION OF A PERMANENT STOMA. CONCLUSION SEVEN OUT OF 10 PATIENTS DID NOT REQUIRE A PERMANENT COLOSTOMY AFTER SNM. SNM SHOULD BE CONSIDERED BEFORE PERFORMING A PERMANENT COLOSTOMY. REPORTED EVENTS: AT THE END OF THE FOLLOW-UP PERIOD 3 PATIENTS HAD A PERMANENT STOMA WITH THE INS EXPLANTED AFTER INSUFFICIENT EFFICACY OF SNM. ONE FEMALE PATIENT DEVELOPED AN INFECTION OF THE INS, WHICH REQUIRED ITS REMOVAL. SHE HAD A GOOD RESPONSE TO SNM, BUT DID NOT WISH TO HAVE INS REIMPLANTATION OR A PERMANENT STOMA. SEE ATTACHED LITERATURE ARTICLE. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913387 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention