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

Model Number 97810

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Energy Output Problem (1431); Application Program Problem (2880); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

B3: event date is not known.Please see b5 for approximate date range, if applicable.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 gastrointestinal/pelvic floor therapy and fecal incontinence.It was reported that they were having issues with their stimulation.The patient stated they had charged everything up (they stated they charged up the ins on (b)(6)2024 but when they went to turn on the therapy, they kept getting an error.The patient further clarified, they were seeing a "system is operating at maximum settings.Therapy cannot be increased." the patient stated they were getting it on every program.The patient stated they would usually go to "1 point something" ma but now on their current program they were only on 0.3 ma.Patient services reviewed the meaning of the message and initially the patient denied that they'd had any falls but then they said "well i had 2 falls," noting the falls weren't recent and the falls hadn't been on the implanted system, that they fell forward, and they thought it was working at the time so they let it go for a little while without charging their ins but then things started to happen.Patient clarified they meant by "things starting to happen" they meant they started experiencing their symptoms again so they charged the ins on 2024-feb-13 and they've been encountering this message.The patient stated that yesterday (2024-feb-14) they were sitting at work and they would lean forward or move a certain way and it "came off." patient clarified, they felt the stimulation go on and then off again and then on and then off again but then it just stopped working and they no longer felt it and they were still getting this message.Patient service redirected the patient to follow up with their managing health care provider about the issue to check the implanted system.The issue was not resolved through troubleshooting.

• Brand Name: INTERSTIM
• 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: 18720690
• MDR Text Key: 335577372
• Report Number: 3004209178-2024-04957
• Device Sequence Number: 1
• Product Code: EZW
• 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: 02/16/2024

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: 08/14/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 02/16/2024
• Date Device Manufactured: 02/23/2021
• 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 Sex: Female