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

Model Number 97800

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Muscle Weakness (1967); Nausea (1970); Vomiting (2144); Dysphasia (2195); Discomfort (2330); Malaise (2359); Loss of consciousness (2418); Constipation (3274); Syncope/Fainting (4411); Insufficient Information (4580)

Event Date 06/27/2022

Event Type  Injury  

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

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that the pt stated they thought the therapy was "stimulating the wrong thing," that it was "stimulating" their bowels and not their bladder.The pt stated there was nothing wrong with their bowels, it was their bladder that they were worried about and that, since implant, they were having trouble going to the bathroom (moving their bowels).The pt denied being constipated, but stated it was very uncomfortable and not consistent and that it was hard to go to the bathroom.They'd have "one little ball after another," and that they needed help making it work for their bladder.The pt also stated they felt the stimulation in their rectal area.Patient services (ps) reviewed programming considerations with the pt and stimulation expectations and the pt connected to see their settings.The pt stated it was really hard to deal with using the external devices, because they were 80 years old and it was scary.At first they had a difficult time connecting to the ins (they stated they had "so many lumps and bumps" on their back side).The pt had difficulty navigating the handset and the application, and it had been determined that the pt had been holding the communicator power button down initially when they were trying to connect.The external devices were functioning as intended and the pt connected to see they were on program (prog) 1.They then switched to prog 3, where they got "something" but it wasn't in their bike-seat area, it was in their buttock.The pt stated they felt it along the "line" of their "crack".Then they stated "yes," it was the bike seat region but they wanted to switch to another program so then they went to program 2.The pt mentioned on the call that the physician's assistant (pa) at their health care provider (hcp) office turned it up once and they thought they were going to explode at the time, commenting that the pa didn't know what they were doing as much as the pt did.The pt was currently not experiencing pain with their stimulation on the call.The pt started increasing the stimulation on prog 2 and stated they felt it in their "butt," where their "cheeks" came together.They stated they thought it was in the bike-seat region and they wanted to try it at this setting (5.0 ma) and that it was comfortable.Ps assisted the pt in ending their session and the pt had powered off their programmer and ps was reviewing bluetooth function and the pt suddenly said they were "experiencing something horrible right now." ps asked if the stimulation was uncomfortable and they said "not that, i'm feeling my head is.I feel like i'm sick to my stomach." ps advised the pt they could assist them in turning the stimulation down and the pt sounded very faint on the call, weak, and said "you're going to have help me on this one".The pt was connecting and said "oh my god this is terrible i can't believe how horrible i feel." the pt got "retry" a few times but it was connecting and the pt said "oh hurry.I think i'm going to faint." ps advised the pt to turn it off.The pt said they were "making the program go away," but they didn't confirm turning it off and they were slurring their words slightly and became unresponsive.The pt's spouse came to the phone and said the pt had "more or less fainted" and the pt woke up and said they wanted to turn the stimulation down but then their spouse said the pt was getting nauseated and the pt began throwing up.The spouse turned the therapy off.Ps advised the spouse to call emergency services or take the pt to an urgent care clinic.The spouse and the pt (the pt was coherent and talking at this time) stated they would do so.The call ended at this point.Ps did not get a chance to inquire further about the pt's hcp or other event details given the circumstances at the end of the call.

• 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: 15202546
• MDR Text Key: 297679628
• Report Number: 3004209178-2022-10053
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: 00763000484668
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/08/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2023
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2022
• Initial Date FDA Received: 08/10/2022
• Date Device Manufactured: 05/05/2022
• 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): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female