MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431); Inadequate Instructions for Non-Healthcare Professional (2956); Data Problem (3196); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Incontinence (1928); Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Urinary Frequency (2275); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding their implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.The patient believed that they were given faulty equipment that was very old and looks like it was used.Patient stated that when they were given the communicator and handset, the communicator was completely dead and they were experiencing some uncomfortable stim, but they could not connect with their implant to turn the device down.The patient wanted to know what settings they should be at.The patient reported that the rep told them to use program 1 and not worry about other programs.The patient added that they feel stim too much in their groin and that stim is uncomfortable.If they shift their weight to the right, the stim really vibrates very hard into her groin and if they stand straight up with vibration disappears.They reported that they have never hurt so bad in their life and thy are having a very bad experience.They are experiencing pain at the implant site and they are hurting so bad in both spots and feels like they "has been mildly raped by an elephant," and it hurts so bad right at the implant site they cannot touch it and feels like someone had punched them in the side with a hard pulsation.Patient services assisted the patient with charging the communicator and external devices and walked the patient through how to adjust settings.The patient adjusted settings from program 3 at 1.0v to program 3 at 0.9v and the stim was then comfortable.Additional information received from the consumer.They stated that the handset is changing programs on its own.Additional information was received from the patient.The patient stated that they are not having symptoms relief at night.They said that they "have it at 0.9v on program 3, and if i go any higher than 0.9v it is too much stimulation in my organs and causes me pain so it's better to leave it at 0.9v but when i go to bed at night i have to get up usually 3 times because i have no control." the patient said that therapy had not worked at night since the implant.The patient said that they had tried programs 1 and 2, and is now on program 3.They clarified that it does work in the day but not at night.They said their hcp told them to leave it on 1.0v day and night, but they had pain in their stomach so they backed it up to 0.9v.Patient services recommended trying program 4 tonight.The patient said they would try it and follow up with their hcp.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a health care professional.It was reported that the cause of the changing programs on its own was not determined, but the rep cam to reprogram the device, and the issue was resolved.No further patient complications are anticipated or expected as a result of this event.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9379023
• MDR Text Key: 173232740
• Report Number: 3004209178-2019-22697
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 11/27/2019
• Supplement Dates FDA Received: 12/17/2019
• Date Device Manufactured: 07/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 73