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)

Patient Problems Emotional Changes (1831); Incontinence (1928); Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Urinary Frequency (2275); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517)

Event Date 07/16/2019

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 (con) regarding a patient who was implanted with a neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.The patient reported that her device is not working.The patient reported that there was no therapeutic effect since implanted.The patient stated that the trial worked.Since implanted, the patient can not make it from the kitchen or bedroom to the bathroom.The patient stated that last night she went through 20 pads and she was not in a good mood today.The patient stated that "when you are up all night long and all day long changing pads and you go through them like you go through water".The patient reported that it had been bad every single day since she had the implant surgery.The patient does not drink after 6:30 pm, she only takes a pill at 8 pm with a sip of water.It was noted that the patient started crying on the call.The patient stated that their patient programmer (pp) showed that stim was on.On the call, patient services walked the patient through using the handset.At first it showed the tutorial.Patient services reviewed how to skip the tutorial.The patient then connected and was at 1.0 v.The handset then was showing device not responding but the patient was able to successfully connect again after she repositioned the communicator.The patient first increased to where stim felt bad and she then went down to 1.3 v and confirmed 1.3 v was comfortable.Redirected patient to healthcare provider (hcp) if problem does not resolve.The patient will monitor symptoms at 1.3 v.If symptoms do not improve and the patient cannot tolerate going higher, the patent will follow-up with the hcp about changing programs.No further complications were anticipated/reported.Additional information was received from the patient on (b)(6) 2019.The ins does not seem to be working as well.Caller states she is going to the bathroom 40 times day and night.Call er states she is on her 3rd pack of 48 pads and she is sick of it.Caller states for the past week or so she has not been feeling the stimulation.Caller states she saw her hcp (healthcare professional) (b)(6) 2019 and they told her she was at 50 percent.The caller states she increased her stimulation from 1.5 to 1.9 v on program 1.During the call caller was able to increase the stimulation to 2.4v on program 1 and felt stimulation in the correct area.Patient was advised to review any directions previously provided by the hcp, and it was reviewed it takes time for body to respond to therapy, therefore titrations should be discussed with hcp and to consider completing voiding diary to track progression/therapeutic response.While on the call, caller states she has a tiny scar and can never find the ins, then stated she found the ins.Additional information was received from the consumer on (b)(6) 2019.The patient reported that they were having a little trouble trying to get the stimulation up more.The patient stated that they went up to 3.0 and then it cuts off.The patient stated that they left it for a minute and then they switched it from on to off and didn¿t feel anything.It was explained to the patient that they were shutting off the therapy.The patient said that they started this on saturday and finished it on sunday.The patient reported that they had been wetting like they ¿didn¿t know what" and noted that they had been going through pad after pad.The patient stated they went to their health care physician (hcp) in november and the hcp said that they were supposed to go through all four programs.The patient stated they didn¿t know that they were supposed to adjust it.While on the call, the patient¿s settings were checked and the patient was on program 1 at 3.2, which the patient said was too high so they brought it down to 3.0 volts and then increased it on the phone to 3.1 volts and the patient stated that it felt better.The patient was told to give it a couple of days and to monitor their symptoms in a diary and it was also explained to the patient that it could take their body a couple of days to adapt.There were no further complications 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 a consumer when asked for the circumstances that led to the trouble getting stimulation up more and it cutting off after going up to 3.0, the patient replied ¿4.8.¿ when asked for the circumstances that led to the stimulation being up too high on program 1 at 3.2 the patient replied that they have a little trouble.No further complications were reported.

• 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: 9508139
• MDR Text Key: 172932029
• Report Number: 3004209178-2019-24315
• 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
• Report Date: 03/02/2020

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: 11/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/21/2019
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 110