BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 21371822 · Received February 13, 2025

    Report

    Report Number
    2182207-2025-00433
    Event Type
    Injury
    Date Received
    February 13, 2025
    Report Date
    February 13, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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: V151154); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2010; EXPLANT DATE (B)(6) 2022. 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/SACRAL NERVE STIMULATION. IT WAS REPORTED THAT THEIR PREVIOUS INS WAS REPLACED, BUT THE PATIENT TOLD THEIR HCP THAT THE THERAPY STILL WASN'T WORKING. THE HCP THOUGHT PERHAPS THE LEAD NEEDED TO BE MOVED. THE PATIENT PUT THINGS OFF FOR A COUPLE OF YEARS, THEN "PROBABLY IN 2003" THEIR HCP TRIED TO TAKE THE LEAD OUT, BUT THEY COULDN'T REMOVE IT. IN 2022, THE PATIENT HAD A NEW INS AND LEAD IMPLANTED (WHICH REPLACED THE PREVIOUS INS AND LEAD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118655 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

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