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

Model Number 97800

Device Problems Unintended Collision (1429); Energy Output Problem (1431); Application Program Problem (2880); Communication or Transmission Problem (2896)

Patient Problems Bruise/Contusion (1754); Incontinence (1928); Pain (1994); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

Event Date 11/01/2023

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and fecal incontinence.It was reported that for the last two days, they'd had little accidents (bowel leakage) but then they had a major accident today at work where they took a good 6 steps and had a really bad cramp and it was like a dam broke and it was running down their legs into their jeans and everything was awful.The patient stated they had to come home from work and take the day off.The patient stated they'd gone back to wearing a pad again when they started having the bowel leakage because they didn't want anything to come out of their jeans.Patient services asked the patient if they had any falls or traumas that led to the return of symptoms and the patient stated that they did have a fall last month on the 14th and that they hurt their upper back where their feet went right up in the air and they came down on their upper back.The patient stated they told their daughter about the fall and lifted their shirt and their daughter "near had a heart attack" because they saw the patient's bruise and lumps on their back.The patient stated their daughter made them go to the er after that and that they had an appointment coming up on 2023-nov-10 with a spinal doctor, but up until 3 days ago, the device seemed ok and the therapy still seemed to be helping them.Patient services reviewed therapy expectations and programming considerations with the patient and the patient was able to connect to their settings.The therapy was on, on program 2 at 1.2 ma.The patient was going to increase the stimulation but then they got a 'device not responding' message because they'd moved the communicator and when the patient connected again the stimulation had gone up.1 ma.The patient stated they didn't think they'd had the chance to press the up arrow to increase the stimulation before they lost communication.Patient services reviewed the therapy settings should not change on its own and reviewed external device function with the patient but is docume nting the occurrence because the patient didn't think they hit the up arrow for the stimulation to increase.The patient was then able to begin increasing the stimulation but they got a message that said "limit reached" at 1.5 ma and couldn't go past that.The patient was unable to read the entire message.Patient services reviewed with the patient that they could try another program however the patient wasn't sure if the managing health care provider (hcp) wanted them to switch programs.Patient services reviewed with the patient to follow up with their hcp to discuss their symptom concerns and to make a program change and to check the implanted system since the fall.The patient was going to continue to monitor their symptoms and reach out to their healthcare provider to discuss their symptom concerns and to check the implanted system.

Manufacturer Narrative

B3: date is approximate.Year is confirmed 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.

• 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: 18117487
• MDR Text Key: 327888404
• Report Number: 3004209178-2023-20377
• 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: Other
• Type of Report: Initial
• Report Date: 11/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 11/03/2023
• Initial Date FDA Received: 11/12/2023
• Date Device Manufactured: 05/05/2023
• 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: 70 YR
• Patient Sex: Female