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

Model Number 3058

Device Problems Energy Output Problem (1431); Environmental Compatibility Problem (2929)

Patient Problems Abdominal Pain (1685); Incontinence (1928); Muscle Spasm(s) (1966); Device Overstimulation of Tissue (1991); Pain (1994); Urinary Retention (2119); Therapeutic Response, Decreased (2271); Discomfort (2330); Ambulation Difficulties (2544)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient was just on a long flight and on the way there it felt like their toes were curling.When they got off the plane, things seemed to improve.When the patient stood up to get off the plane, they felt severe pain.The pain was pinching the right side of their vagina.The patient stated that when they were in ¿lower elevation¿ they did not notice anything.They turned the settings down today and got immediate relief but had signs of retention.The patient was not sure what caused this but noted that, maybe, they had been sitting for too long and trying to pull luggage.There were no further complications reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer.It was reported that the patient had to increase their stimulation up and down.It would be too strong but then they had retention symptoms.They said lots of times it had been uncomfortable stimulation all through the time they had the stimulator.The last few months stimulation has not been comfortable.They said that their symptoms might seem like they decrease when the stimulation is too high.When the patient went to bed last night and didn't turn the stimulation down, their toes were curling and they were having a pinching in their vaginal area.The morning of the call they had symptoms of urine retention and mild fecal incontinence, so they increased the stimulation.The return of symptoms had gradually gotten worse a few months ago or a couple months ago.The patient had other health problems too, so they weren't focused on the stimulation.When the stimulation is too strong and pinching on the right side in the vaginal area, it will hurt in the same area when having sex.The patient went to obgyn and they said there is nothing wrong and to go to the urologist, that was last year in 2019.They were concerned they had gambray syndrome and as they healed the pain when having sex went away, but now the pain is back.Patient services redirected patient to follow up with their healthcare professional.

Manufacturer Narrative

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

Event Description

Additional information was received.The patient experienced aching and couldn't stand or put weight on their foot while on their trip.They repeated that they experienced urinary retention.No device issue alleged / identified.No further patient symptoms or complications were reported.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.They reported that the patient continued to adjust the strength of the stimulation up and down to get relief from their mild fecal incontinence.Gradually improved but not maintain consistently.The spread out of stimulation to decrease vaginal pinching is helping so far.The patient continued to turn down the stimulation to decrease the vaginal pain and toes curling and turned it back up again to decrease their mild fecal incontinence.Alternate up and down.Sitting prolong period of time, like on the flight, definitely increased side-effects from the stimulation.On the flight home, when the patient stood up on the plane in (b)(6) for a flight change, the pain was severe and the patient was crying.While sitting during the flight, the patient bladder was aching but had no vaginal pain until they stood up and nearly collapsed.They managed to get the controller out to decrease the stimulation setting.Pain decreased immediately and gradually almost completely.The patient did see a company technician on (b)(6) 2020.They reset the program and recommended the wire and electrodes be replaced when the battery in the implanted device is replace in about 6 months.Patient services said it might be too close to a nerve and that it is going down the patient's leg, causing the toes to curl.

• 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
• MDR Report Key: 9437618
• MDR Text Key: 169883484
• Report Number: 3004209178-2019-23360
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 69