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); Inappropriate/Inadequate Shock/Stimulation (1574); Environmental Compatibility Problem (2929); Insufficient Information (3190)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Electric Shock (2554); Insufficient Information (4580)

Event Date 03/08/2024

Event Type  malfunction  

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 this morning the stimulator started shocking the patient - three little shocks.The patient was just laying in bed and the cat was wanting the patient to get up.It was not the little pain when you mess with the amplitude.The first one the patient tolerated.The second one they said "this is not right".The third one they  jumped up and said they were going to go get their thing and try to turn it off and it quit.It was like getting stuck with a pen in the scrotum.Patient has not had any falls, accidents, or medical procedures.Patient said they had never had anything do any good.The therapy had not helped their symptoms since implant.They used a two hand vibrator on their spine of their lower back when they had lifted something or hurt themselves anywhere on back.They wanted to know if patient services thought it could have activated it from the night before when they vibrated.  they hadn't gotten any results yet.They were new at this and never had success with it.About a week ago they changed programs.A week ago they went from program 5 to program 4 at 2.0 and this had just happened.They didn't know if it was not working or was working because they hadn't seen any success with the  device.Patient was on program 5 and it wasn't working.Patient went to 6.0ma and 6.5ma on program 5 and it hurt like hell so they went back to the doctor and the pa told them to change to a different program.They said, it was like an electrocution when it hurt.Patient services  asked if they were moving or anything and they said no.The issue was not resolved through troubleshooting.Patient will monitor  symptoms and call back if they need further assistance.

• 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: 18885665
• MDR Text Key: 337770394
• Report Number: 3004209178-2024-06866
• 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: Other
• Type of Report: Initial
• Report Date: 03/12/2024

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: 03/08/2024
• Initial Date FDA Received: 03/12/2024
• Date Device Manufactured: 10/30/2023
• 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
• Patient Age: 80 YR
• Patient Sex: Male