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

Model Number 3058

Device Problems Disconnection (1171); Migration or Expulsion of Device (1395); Unintended Collision (1429); Insufficient Information (3190)

Patient Problems Pain (1994); Shaking/Tremors (2515); Sleep Dysfunction (2517); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2023

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id 3889-28 lot# va25mft implanted: (b)(6)2020 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3889-28, serial/lot #: va25mft, ubd: 05-feb-2024, udi#: (b)(4) b3.Date is estimated; year is 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.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor therapy.It was reported that when they lay flat in bed at night they wake up "uncontrollably shaking".Patient said they started having problems "about 3 months ago".Patient said that they sent a message to their previous healthcare provider asking if this could have anything to do with the implanted device and the healthcare provider told the patient that the only way to know for sure is to turn the stimulation off when the shaking is happening.Patient turned off the stimulation and the shaking stopped.Patient stated they have "not been using it" and currently have it ins turned off, which they said "creates other problems".Patient mentioned that they moved and are looking for a hcp, but had not been able to find anyone using the physician locator.Patient service specialist documenting reported event.Patient requested physician listings in their area.Patient service specialist was able to generate a list of physicians in their area and emailed list to the patient.Additional information was received from the patient.Patient called back and reiterated that they were having some issues with their stimulator and that they would wake up uncontrollably shaking in bed.They reported that they have located a new health care provider (hcp) and that they've gone a couple times but the hcp didn't know the clinical part about how to reprogram their stimulator.The patient stated there was just one nurse there who knew how to work with the devices and they determined the first time they visited with the hcp in november 2023 that they had an electrode that was not connected.The patient stated the nurse was trying to help the patient figure out what programs to use and what program to avoid.The patient stated the nurse told them to avoid programs 4 and 7 but the patient stated they didn't even have those programs and that their previous hcp since the beginning had them programmed with programs 1, a, b, c <(>&<)> d.The patient was hoping to locate someone who knew how to program/reprogram their ins because the nurse wanted the patient to come back to the office again to try different programs because it wasn't helping and the drive round-t rip was 120 miles and the patient didn't want to go all the way out there again unless someone could help them figure out what to do.Patient services provided the patient with the technical services phone number and the national answering service number to give to the nurse and advised the nurse could always call technical services when working with the patient or they could page a medtronic representative to come to the patient's next appointment.The patient stated they would provide the nurse with the numbers and continue working with the nurse to find a good program setting.

Event Description

Additional information was received from the patient.They clarified the statement of "having some issues with their stimulator" further by noting "in (b)(6) 2023 i woke during the night with uncontrollable shaking.I contacted [doctor] to see if the stimulator could cause this.Doctor stated the only way to know was to see if i could turn it off while it was happening." the issue was not caused by normal battery depletion.The likely cause was noted as being "i fell onto my concrete patio at my home.Landed on my butt.Felt the battery move deeper in my butt." the steps taken/will be taken towards resolution were noted to be "(b)(6) 2023 seen in er nerve pain, told doctor about shaking.Made appointment with urology (2 mo wait) 6 weeks into waiting doctor left.Scheduled appointment with new doctor.1 mo wait to be seen, then had covid and rescheduled, 1 mo wait.Finally saw [doctor] in (b)(6) 2023." the cause of the electrode not being connected was listed as unknown but patient noted "i think so" on the side of the response.The likely cause was noted as being "fall on concrete patio at my home.Landed on my butt.Felt battery pack move deeper in buttock." the steps taken/will be taken were noted as being "revision was done (b)(6) 2024.It works great again." the issue was reported as being resolved.

Manufacturer Narrative

Continuation of d10: product id 3889-28 lot# va25mft implanted: (b)(6) 2020 product type lead.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.

• 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: 18656217
• MDR Text Key: 334746546
• Report Number: 3004209178-2024-03822
• Device Sequence Number: 1
• Product Code: EZW
• 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,Followup
• 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 Expiration Date: 04/28/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 04/15/2024
• Date Device Manufactured: 11/01/2019
• 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...."; "SEE H11...."
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 147 KG