BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 7230323 · Received January 31, 2018

    Report

    Report Number
    3004209178-2018-01718
    Event Type
    Malfunction
    Date Received
    January 31, 2018
    Date of Event
    December 28, 2017
    Report Date
    February 1, 2018
    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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DISFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. HCP IS WITH THE PATIENT AND IS REPORTING THE FOLLOWING ABOUT IMPEDANCES. CALLER SAYS THE PATIENT IS HAVING URETHRA PAIN ONLY WHEN THEY INCREASE THEIR STIMULATION TOO MUCH, BUT THEY'VE HAD IMPROVEMENT ON THEIR DRIBBLE SAYING THEIR PADS HAVE JUST SLIGHT DRIBBLE; THE PATIENT IS GETTING MORE THAN 50% RELIEF. ON 1.0V AND 210 PULSE WIDTH (PW), THE HCP REPORTS: C0: 1016 OHMS, C1: 1016 OHMS, C2: 1016 OHMS, C3: 1016 OHMS, 01: >4K OHMS, 02: >4K OHMS, 03: 2026 OHMS, 12: >4K OHMS, 13: >4K OHMS, AND 23: 1909 OHMS. IT WAS REVIEWED TO RE-RUN THE ELECTRODE IMPEDANCE AT HIGHER AMPLITUDE IF MEDICALLY APPROPRIATE. THE HCP SAYS THEY SWITCHED THE PATIENT FROM PROGRAM 3 TO 2. ON 3.3CV, 210 PW, AND 14 HZ, THE HCP REPORTS: C0: 1027 OHMS, C1: 1027 OHMS, C2: 1027 OHMS, C3: 877 OHMS, 01: 1741 OHMS, 02: 2068 OHMS, 03: 1681 OHMS, 12: 1741 OHMS, 13: 1599 OHMS, AND 23: 1549 OHMS; TROUBLESHOOTING RESOLVED THE REPORTED ISSUE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL (HCP) RESPONDED TO A LETTER. THE HCP WASN'T SURE WHAT CAUSED THE HIGH IMPEDANCES ON PROGRAM 3. HOWEVER, THE HIGH IMPEDANCE ISSUE ON PROGRAM 3 WAS RESOLVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74538 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR