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

Model Number 97800

Device Problems Energy Output Problem (1431); Unauthorized Access to Computer System (3025)

Patient Problems Headache (1880); Undesired Nerve Stimulation (1980); Numbness (2415); Paresthesia (4421); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id a52300 lot# serial# unknown, product type software section d information references the main component of the system.Other relevant device(s) are: product id: a52300, serial/lot #: unknown.B3: date is estimated; month and year are valid.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

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 patient said their urologist and the representative think they need to send back their handheld device because their ex boyfriend put a bunch of apps on it and got into all the devices.Patient said they do not know how he did it through google apps and files.Warm transferred to mobility to discuss handset replacement.Called pt back.Pt said around the 8th or the 13th of december they were in bed one night and notice their whole body was numb and tingling, they were yanking their jaw right and left, they felt really weird like they were having a stroke, it was like it was giving different megahertz to their body like they have a really bad headache, so they turned their stimulator off and when they did it stopped happening.Pt said they only turned it back on when they went for their follow-up and saw the bluetooth, wi-fi and location were on and they had not been on when they first got the equipment.Pt said told the doctor and rep about it and was told it was not possible to do.Pt said therapy has been off but they want to turn it back on.Pt said they are pressing criminal charges and will need the report once the handset is sent back to manufacturer.Pt said the ex-boyfriend hacked into the modem router and apps a32 and 23, developer apps, wi-fi, dir ect, advanced, developer mode controls, all the devices.Pt said their ex-boyfriend remotely gained access, cloned and mirrored all the devices.Pt said, he has control of everything he can go in there and reset the pin and reset passwords and everything.Redirected to the hcp.

• 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: 19106358
• MDR Text Key: 340904514
• Report Number: 3004209178-2024-09090
• 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: 04/15/2024

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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/15/2024
• Date Device Manufactured: 09/09/2023
• 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
• Treatment: "SEE H11...."
• Patient Age: 50 YR
• Patient Sex: Female