BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 25049441 · Received April 30, 2026

    Report

    Report Number
    2182207-2026-01136
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    February 9, 2026
    Report Date
    April 30, 2026
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: FOREIGN COUNTRY ISRAEL ISSA, A., LUTRIN, D., YARCHI, S., SKVORTSOV, R., ISA, R., WEKSLER, Y., ET AL. (2026). SACRAL NEUROMODULATION IMPROVES BOWEL FUNCTION IN PATIENTS WITH LOW ANTERIOR RESECTION SYNDROME. TECHNIQUES IN COLOPROCTOLOGY. (2026) 30:32. HTTPS://DOI.ORG/10.1007/S10151-025-03263-8 CONTINUATION OF D10: PRODUCT ID NEU_UNKNOWN_LEAD LOT# UNKNOWN: PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN_LEAD LOT# UNKNOWN: PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN_LEAD LOT# UNKNOWN: PRODUCT TYPE LEAD PRODUCT ID NEU_INTERSTIM_INS LOT# UNKNOWN: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID NEU_INTERSTIM_INS LOT# UNKNOWN: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR 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; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UBD: UNKNOWN, UDI#: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UBD: UNKNOWN, UDI#: UNKNOWN; PRODUCT ID: NEU_INTERSTIM_INS, SERIAL/LOT #: UNKNOWN, UBD: UNKNOWN, UDI#: UNKNOWN; PRODUCT ID: NEU_INTERSTIM_INS, SERIAL/LOT #: UNKNOWN, UBD: UNKNOWN, UDI#: UNKNOWN A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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. B.5. 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 SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    REPORTED EVENTS: 1. ONE SUPERFICIAL WOUND INFECTION TREATED WITH ANTIBIOTICS. 2. ONE F LEAD EXTRUSION RESOLVED WITH REVISION. 3. ONE F LEAD EXTRUSION REQUIRED DEVICE REMOVAL. 4. TWO DEVICE REVISION DUE TO LEAD DISPLACEMENT. 5. ONE DEVICE REVISION DUE TO DEVICE UPGRADE. 6. ONE DEVICE REVISION DUE TO UNKNOWN REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597975 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention| O "SEE H11...."