BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM X

    MDR report key: 21023511 · Received December 26, 2024

    Report

    Report Number
    3004209178-2024-24151
    Event Type
    Injury
    Date Received
    December 26, 2024
    Date of Event
    May 29, 2024
    Report Date
    January 10, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00763000484668
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DATE IS APPROXIMATE. YEAR IS CONFIRMED VALID. CONTINUATION OF D10: SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME SURESCAN; PRODUCT ID 978B128 (LOT: VA2P5YA); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2023; EXPLANT DATE (B)(6) 2024. 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

    H6 CODING HAS BEEN MOVED TO THE INS. THE LEAD HAS BEEN MADE A NON-COMPLAINT. 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 FECAL INCONTINENCE AND URINA RY/BOWEL DYSFUNCTION. IT WAS REPORTED THAT ABOUT 4-8 WEEKS BEFORE THEY RECEIVED THEIR REPLACEMENT SYSTEM, THE PATIENT NOTICED THE SITE WAS IRRITATING WHEN SITTING IN THEIR LA-Z-BOY CHAIR. THE PATIENT WENT TO SEE THEIR MANAGING PHYSICIAN WHO VISUALLY CHECKED AND WAS TOLD THAT EVERYTHING LOOKED FINE HOWEVER THE PATIENT SAID THE DISCOMFORT PERSISTED. THE PATIENT SAID THAT THEY CONSULTED WITH SOMEONE AT THE MANUFACTURER AND THE PATIENT WAS SCHEDULED FOR AN X-RAY, WHICH REVEALED THAT THE WIRE HAD DISCONNECTED IN SOME KIND OF WAY AND CURLED UP IN PATIENT'S BODY. WHEN ASKED, THE PATIENT SAID THEY HADN'T HAD ANY FALLS OR TRAUMA. THE PATIENT RECEIVED A REPLACEMENT SYSTEM ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995551 INTERSTIM X STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 97800 00763000484668

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention SEE H11...