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

Model Number 97800

Device Problems Display or Visual Feedback Problem (1184); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 10/24/2022

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.The reason for call was the patient called with their spouse on the line and reported that they'd gotten shocked, "really shocked" two times now and they were wondering what they were doing wrong? the patient stated they'd hold the communicator over their implant site and that their spouse would be holding the handset and when the spouse hit 'find device,' that's when the patient experienced the shocking stimulation in their groin area.The patient stated that when they connected, the tutorial would pop up and they weren't able to tap anything to go through it, it wouldn't respond to anything and then finally the screen would just change to the patient's regular settings screen so they were never able to get to the "congratulations" screen where they would get the option to check the box that says "do not show this tutorial again." the patient stated they were able to connect just fine the first time without experiencing shocking and that they had gone to their managing health care provider (hcp) office about a week after implant and that they'd been able to connect with no shocking, but on (b)(6) 2022, that was when the patient's spouse hit find device and the patient first experienced the shocking stimulation in their groin.After the tutorial screen went away, they were able to make an adjustment to their settings however yesterday (b)(6) 2022 the patient had wanted to increase their stimulation a little bit higher and when their spouse hit "find device" on the handset the patient experienced the shocking again only this time it was much worse and very painful.The spouse said they ran out of the room with the handset to break the connection so the shocking would stop and that the patient experienced pain from the shocking for hours afterwards.The patient stated it wasn't intense pain after they were no longer connected, but it hurt for a while afterwards.Patient services advised the patient to tell their hcp about it and to have them take a look at everything before they tried to connect again.The patient stated they were going to call their hcp as soon as they ended the call with patient services.

Manufacturer Narrative

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.

• 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: 15788553
• MDR Text Key: 307682529
• Report Number: 3004209178-2022-14963
• 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: P970004
• 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: 11/14/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 11/14/2022
• Date Device Manufactured: 08/29/2022
• 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 Age: 75 YR
• Patient Sex: Female