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

Model Number 3058

Device Problems Premature Discharge of Battery (1057); Failure to Deliver Energy (1211); High impedance (1291); Migration or Expulsion of Device (1395); Unintended Collision (1429); Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927); Impedance Problem (2950); Insufficient Information (3190)

Patient Problems Incontinence (1928); Skin Erosion (2075); Urinary Frequency (2275); Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the patient's son believes there to be something wrong with his mother's device.

Manufacturer Narrative

Continuation of d10: product id 3889-28, lot# va20d3r , implanted:(b)(6) 2019, product type lead.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

Additional information was received from the patient's friend or family member.The patient called reporting that they had a fall on (b)(6) 2021, broke the femur and messed up an artificial knee.The caller stated that the patient is worried that the fall may have dislodged components of the system because a couple of days after the fall the patient noticed a return of symptoms.The patient has been peeing constantly without feeling the urge.Patient said they fell three weeks ago, and had to wait a couple days before they operated.They think they operated three weeks ago last sunday.Ever since the operation, the patient has been peeing every five minutes.They said the skin is breaking down.Two days after surgery they had a bowel obstruction.Patient said they are peeing to often.When they are done changing them, they aren't even out the door and they have gone again.The communicator wasn't charged and that the patient doesn't think they turned the device off because they didn't have it with them.The patient thinks they are at 4.3 volts and stated it was working fine after the fall and didn't start to have issues until after the surgery.Patient can't walk right now and probably won't be able to for several months so can't go to see the healthcare provider (hcp) that manages the device.The patient was advised to charge the communicator to check if the stimulation is on.No further complications were reported.

Event Description

Additional information was received from a manufacturer representative (rep).The rep reported that the fall caused the impedances to be high and non-functioning for symptom relief, and not being able to feel stimulation.

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.

Manufacturer Narrative

Patient code e2328 does not apply to this event.Please disregard its inclusion in the previous report.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

Additional information was received from a patient via a manufacturer representative (rep).A return of symptoms post fall was reported.The rep stated that there was premature battery depletion due to the patient turning up the amplitude to try to get stimulation and symptom relief.The rep said that the environmental/external patient factors were that the patient stated that they¿d had a bad fall (not alleged to be related to the device/therapy) sometime in (b)(6) 2021 and fractured their femur and hip for which they¿ve had multiple subsequent surgeries for the injuries.Since then, the rep stated the patient has not had symptom relief and noted that they were not able to really feel stimulation so they were increasing the stimulation which caused premature depletion.The rep reported that the diagnostics/troubleshooting performed were that impedances were checked per the health care professional (hcp) in t he office and were said to be abnormal.The rep reported that the actions and interventions that were taken to resolve the issue were that that the system was replaced on (b)(6) 2021, the devices were reported to be discarded by the customer.The rep reported that the issue was resolved at the time of the report.On (b)(6) 2021, the manufacturer representative (rep) reported that they received a call on (b)(6) 2021 from the office that the patient had passed away on (b)(6) 2021 of an abdominal aneurysm.The rep stated that there was no relation to the procedure and that they just wanted to notify the manufacturer company about the occurrence.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11353552
• MDR Text Key: 234635605
• Report Number: 3004209178-2021-02925
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/25/2021

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: 11/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 02/22/2021; 05/07/2021; 06/04/2021
• Supplement Dates FDA Received: 02/25/2021; 06/04/2021; 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR