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

Model Number 3058

Device Problems Unintended Collision (1429); Energy Output Problem (1431); Insufficient Information (3190)

Patient Problems Bruise/Contusion (1754); Pain (1994); Discomfort (2330); Shaking/Tremors (2515); Constipation (3274); Swelling/ Edema (4577); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2022

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that patient (pt) states due to having covid back in 2020, they are struggling with vertigo and chronic fatigue.Pt states because of the vertigo they have fallen a lot.Pt states the first fall was right before thanksgiving and they fell on their hip bone and their stimulator was not on at the time, and the second was the last shopping day before christmas where the stimulation was on.Pt states the 2nd fall was much harder on a tile floor and they landed on their hip bone where the device is located.Pt states it was really bruised and swollen.Pt states their entire body felt jammed, even their shoulder, and was feeling pain.Pt states they turned stim off and iced it and kept pressure off it.Pt states they couldn't sit there for almost 3 weeks and sat on their other butt cheek.Pt states they also came down with covid again over new years.Pt states now as of last week, they spent 4 hours sitting on a bar stool and had to put some weight on that area.Pt states that night they started experiencing stabbing rectal pain.Pt states if they sat on that hip bone, their leg on that side would shake so profusely that their entire body will shake.Pt states they can feel the wire on that hip bone and if they take the pressure off of it, the shaking stops.Pt states they are still having rectal pain and pinching and sharpener pain in the clitorial area and will migrate from one spot to the other if they have a bowel movement.Pain was like stabbing with a knife and feels like they can feel a pulse in their hip bone area.Pt mentioned they did turn the stim back on a week prior to sitting on that stool.Pt states the doctor did order an x ray but they are also telling them to call manufacturer and will not call the pt back.Pt states they are worried about permanent nerve damage.Pt saw their primary doctor and they ordered an x ray and said the tailbone and back look ok, even thought pt mentioned they were sore.Pt states it's been a week since the doctor said they'd call them and the symptoms are getting worse and worse.Pt states if they turn it off the pain is still there, but if it's on the nerve pain is more intense and they have the leg shaking issue if they put pressure on it.Pt states they are takingpowdered stuff to help their bowel movements be soft.Pt states they are also taking pain medicine and haven't had a bowel movement in 3-4 days.Pt states the last bowel movement made it feel like they were being stabbed in the butt.Pt states they tried calling their rep today and it just goes to voicemail.The patient was redirected to their healthcare provider to further address the issue.The patient's relevant medical history included pt also mentioned had a hip surgery as well since covid over new years 2022. the patient called back again repeating symptoms and expressing they are in flight or fright because they do not know if their medical symptoms require urgent medical attention or if it can wait.The patient does not want to seek local medical attention or go to the er.The patient reported the managing physician's office will not provide them with guidance and told them to call manufacturer.Reviewed the role of manufacturer and that we cannot provide medical advice.Offered to bridge patient to the crisis line per their remarks about being in flight or fright and patient indicated they have a emergency line they can call with their medical health professional. the patient eventually ended the call stating that their managing physician's office is calling them back.

Manufacturer Narrative

Concomitant medical products: product id 3889-41 lot# va21s4r implanted: (b)(6) 2019 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3889-41, serial/lot #: (b)(4), ubd: 14-aug-2023, udi#: (b)(4) date of event: date is estimated; month and year are 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 II
• 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: 16335566
• MDR Text Key: 309273056
• Report Number: 3004209178-2023-01845
• 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: 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: 02/09/2023

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: 02/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 02/09/2023
• Date Device Manufactured: 08/31/2018
• 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: 60 YR
• Patient Sex: Female