MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Intermittent Continuity (1121); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Communication or Transmission Problem (2896); Unauthorized Access to Computer System (3025)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Twitching (2172); Cognitive Changes (2551); Paresthesia (4421); Insufficient Information (4580)

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

Event date is estimated.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 fecal incontinence and gastr ointestinal/ pelvic floor.It was reported that for years their interstim device worked very well for the patient (pt).It resolved their issue and so they turned it off, but, starting in march or april they feeltheir device turning on without pt initiate it.They notice instances where can feel it turn on by itself and they feel it very strong in their vagina and in their left foot then a couple of months ago they felt pain in their right hip and could barely walk.Pt said: recently they could not write, they lost the ability to write, they felt tingling and they are right handed.Pt also reported when they type, the words typed were not what pt was typing it was as though someone had turned their device on.Pt said right now they feel vibration under their armpit and vibration in their brain and their eye is twitching involuntarily.Pt said they remember what the feeling of stimulation felt like when they used their stimulator, it was an unsettling vibration but now the vibration has shifted they feel it in their eye, their eye is twitching.Pt said they are frustrated they have "been compromised" later clarified compromised meant " hacked".Pt denied falls and accidents, they are not exposed to emi.Redirected to have their system checked in person by their doctor. pt also reported when they try to synch with their remote, they got poor communication screen, pt said they never had an antenna.Tried to do troubleshooting the programmer however pt said they wanted to take it with them to their doctor.  .

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

The healthcare provider indicated that they have not seen this patient since 2016.The patient repeated information about how the device will involuntarily turn on.The reiterated that they are having cognitive issues where they lost the ability to read and write.In addition, spontaneous vibrations inside their vagina, foot, and underarm.A few months ago, they couldn't feel their legs while the device was on.Also, on (b)(6) 2022, they felt their eye was twitching in addition to severe brain fog.They cannot connect to their device nor collaborate with it.It appears that the device has malfunctioned or someone has access to it.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 15448292
• MDR Text Key: 306099562
• Report Number: 3004209178-2022-12039
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

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 Expiration Date: 03/14/2015
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 09/19/2022
• Supplement Dates Manufacturer Received: 09/19/2022
• Supplement Dates FDA Received: 09/22/2022
• Date Device Manufactured: 09/18/2013
• 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 H10...."
• Patient Age: 37 YR
• Patient Sex: Female