BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 14118923 · Received April 15, 2022

    Report

    Report Number
    3004209178-2022-04807
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Report Date
    April 15, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT KEPT GETTING ZAPPED WHEN THEY TRIED TO GET AN MRI; IT WAS NOTED THEY HAD A BRAIN TUMOR (NO ALLEGATION) AND NEEDED TO HAVE AN MRI YEARLY. THEY SAID THEY TURNED OFF THE STIMULATION BEFORE THE MRI AS SOON AS THE MRI MACHINE TURNED ON THEY GOT ZAPPED AT THE IMPLANT AND DOWN THEIR LEFT LEG CAUSING A SHARP PAIN. ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER REITERATED WHAT THE PATIENT SAID.  IT WAS FURTHER NOTED THEY WERE GETTING HEAD ONLY SCANS AND THE INS WAS TURNED OFF PRIOR TO THE SCAN USING A 3037 PROGRAMMER. THE HCP REPORTED THAT THEY HAD BEEN DOING SCANS ANNUALLY SINCE 2017, THE PATIENT WAS NOT GETTING A SCAN THE DAY OF REPORT, BUT THEY WERE IN THE NEAR FUTURE. IT WAS NOTED THEIR LAST SCAN OCCURRED IN (B)(6) 2021.  IT WAS ALSO NOTED THAT A MANUFACTURER REPRESENTATIVE (REP) HAD INTERROGATED THE DEVICE THE DAY OF REPORT AND NOTED THE FOLLOWING ELECTRODE IMPEDANCES ON THE CLINICIAN PROGRAMMER: C0: 1016 OHMS C1: 1205 OHMS C2: 1084 OHMS C3: 1016 OHMS 01: 2026 OHMS 02: 2026 OHMS 03: 1909 OHMS 12: >4K OHMS 13: 2026 OHMS 23: 1909 OHMS CALLER REPORTS PATIENT IS CURRENTLY PROGRAMMED: PROGRAM 1: 3+0- PROGRAM 2: 3+ 1- PROGRAM 3: 2-0+ PROGRAM 4: 3-0+ PROGRAM 1 WAS ACTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907606 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 Female