BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM X

    MDR report key: 22714832 · Received August 5, 2025

    Report

    Report Number
    3004209178-2025-13213
    Event Type
    Injury
    Date Received
    August 5, 2025
    Report Date
    August 28, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00763000484668
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE IS NOT KNOWN. PLEASE SEE B5 FOR APPROXIMATE DATE RANGE, IF APPLICABLE. SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME INTERSTIM; PRODUCT ID 3889-28 (LOT: V012404); PRODUCT TYPE: 0200-LEAD. 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.

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE INS (S/N: (B)(6) REVEALED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) PASSED FUNCTIONAL TESTING; HOWEVER THE SETSCREW WAS BACKED OUT TOO FAR. ANALYSIS OF THE LEAD (LOT#: V012404) REVEALED THAT CONDUCTOR 0 WAS BROKEN AT THE CONNECTOR WELD SITE, 1.6 CM FROM THE PROXIMAL END. AND THAT CONDUCTORS 1, 2, AND 3 ARE BROKEN 5.0 CM FROM THE DISTAL END. CONTINUATION OF D10: PRODUCT ID 3889-28 LOT# V012404 IMPLANTED: (B)(6) 2006 EXPLANTED: (B)(6) 2025 PRODUCT TYPE LEAD. 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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 3889-28 LOT# V012404 IMPLANTED: (B)(6) 2006 EXPLANTED: (B)(6) 2025 PRODUCT TYPE LEAD 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

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HIGH IMPEDANCE ON THE DAY OF SURGERY. ALL IMPEDANCES WERE GREATER THAN 4000 ON ALL COMBINATIONS EXCEPT 3 AND CASE. THEY WERE UNABLE TO TURN UP ANY PROGRAMS PAST 0.6 EXCEPT A CUSTOM PROGRAM CASE (-) 3 (+). THERE WERE NO OTHER STIMULATION ISSUES REPORTED AS A RESULT OF THIS ISSUE. TROUBLESHOOTING WAS PERFORMED AND INCLUDED TRYING ALL PROGRAMS FOR SENSATION AND COULDN'T TURN PAST 0.6 UNTIL THE NOTIFICATION OF REACHING "MAX SETTINGS" WAS RECEIVED. THE CAUSE WAS NOT KNOWN. THE PATIENT HAD A RETURN OF THEIR BASELINE SYMPTOMS OF URINARY INCONTINENCE. THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2643493 INTERSTIM X STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 97800 00763000484668

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention "SEE H11...."| "SEE H11...."| SEE H11...