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

Model Number 97800

Device Problems Migration or Expulsion of Device (1395); Energy Output Problem (1431); Application Program Problem (2880); Insufficient Information (3190)

Patient Problems Nerve Damage (1979); Device Overstimulation of Tissue (1991); Urinary Frequency (2275); Abdominal Distention (2601); Constipation (3274); Insufficient Information (4580)

Event Date 04/30/2023

Event Type  Injury  

Manufacturer Narrative

B3.Date is estimated; year is valid.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

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence and urina ry/bowel dysfunction.It was reported that they have been having problems with their bowels for about a month.Patient states they had the device implanted to help control fecal incontinence but now they are having a hard time having bowel movements at all.Patient confirmed that it's almost working too much.The patient also stated they are urinating a lot more than they were before they got the implant.Patient said their bladder seems to be ok but then it's out of whack again.Patient states they are taking mybetric for their bladder as well as some gummies to help them.Patient states they spoke to their doctor about this but they said to call medtronic.Patient services reviewed patient could consider switching programs.Reviewed how to switch programs.Patient was able to successfully switch programs and increase stim to a comfortable level.Patient will maintain stimulation level and will continue to track symptoms.Redirect to doctor if issue persists.Additional information was received from the patient.Caller called back and reports that their bowels are not working anymore and they have to take stool softeners and laxatives.The caller is concerned that the stimulation is too high.The doctor directed the patient to call medtronic.Reviewed medtronic role.Reviewed options for turning the stimulation down, or off, or changing programs.The caller will try this and see if it has an impact on the bowel movements.Patient called back in regards to this case with a continuation of therapy issues.Patient said they need to change programs to help with their therapy but aren't able to because they can only access programs 1-3.Ps asked if there were more programs available and they weren't able to change or if those were the only programs available.Patient connected to their ins and said it's "acting crazy".Patient said they can't change programs or increase stimulation and saw 'max settings message'.Reviewed max settings message and redirected to hcp.Patient said they've had issues with the ins since they've started.Patient said they have an appt with hcp next week and will follow up then.Additional information was received from the patient.They reported that the cause of the stimulation output being too high was not determined.They noted the likely cause as being "low, change in activity level" and wrote that the "device will not change to higher program stuck on #3.Bowels just stopped working after using device.Experiencing a lot of bloating.The steps taken to resolve the issue were noted as "talked to [doctor] and company, one told me to talk to the other." the issue was reported as not yet being resolved.Additional information was received from the patient.Patient called back to inquire if their doctor called in to us like they said they would.Reviewed we do not have visibility to that.The caller reported that the therapy really hasn't working since implant.The caller mentioned that the device was "stuck on program 3".The caller reports that their bowels stopped working and they need a strong laxative to be able to go.The caller added that this was not the problem prior to implant and they think they felt something move with the system and then they stopped going to the bathroom.The caller is considering explant and reports they are concerned they have damage to their nerves.Agent advised caller that they would request a replacement handset and we can start with that.Additional information was received from the patient.The patient (pt) called back to get assistance with pairing new handset.Healthcare it was conferenced in to allow permissions and then pt was successful with connecting to the implant.Pt reported seeing system is operating and maximum settings and is again, "stuck on 3." pt confirmed they were referring to the stimulation level.Pt services reviewed equipment is functioning properly but pt will need to get in to see doctor to have device checked.

• Brand Name: INTERSTIM X
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17982150
• MDR Text Key: 326237111
• Report Number: 3004209178-2023-18070
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: 00763000484668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/21/2023

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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/21/2023
• Date Device Manufactured: 12/23/2022
• 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 Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 57 KG