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

Model Number 3058

Device Problems Therapy Delivered to Incorrect Body Area (1508); Insufficient Information (3190)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Urinary Frequency (2275); Insufficient Information (4580)

Event Date 10/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient with an implanted neurostimulator (ins) for gastrointestinal/pelvic floor.It was reported by the patient that they were not getting therapeutic benefit and that they were feeling stimulation in the thigh.The patient & technical services (pats) agent did not ask about the circumstances that led to the reported issue.The patient noted that had tried going through all 7 programs and felt stimulation more towards the labia on program 5.It was noted that after about 15 minutes on the phone, the patient claimed the stimulation was felt in the thigh and down the leg.Patient services reviewed the option of going through the programs again to see which one targeted the pelvic floor the best.The patient was going to monitor their symptoms and follow up with the health care professional (hcp) as needed.No further complications were reported at this time.

Event Description

Additional information was received from the patient.They reported that when they had the device changed in 2020 it has really never worked and had leg pain but that has resolved.The pain was from the knee to the ankle from the minute they had it put in.Patient said she has been on program 7 at 1.2ma for a long time.Today they increased it to 2.2 but it is annoying.On the call the patient decreased to 2.1ma and then didn't feel the stimulation.Told pt to monitor symptoms for a couple days and see if symptoms improve.Patient is going to the bathroom every 20 minutes and can barely get to the bathroom.When they tested the stimulation in surgery it woke her only at 0.1, that is all they had it at for a while.Then a year later they could go higher on amplitude.Patient said they always felt stimulation in a different place.Even a few weeks ago it was in lower part of buttocks and today feel in leg.No further complications were reported/anticipated at this time.

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.

• 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
• 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: 10834086
• MDR Text Key: 219366786
• Report Number: 3004209178-2020-19906
• 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,Followup
• Report Date: 12/08/2021

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: 09/28/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 11/10/2021
• Supplement Dates FDA Received: 12/08/2021
• Date Device Manufactured: 03/30/2020
• 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: 70 YR
• Patient Sex: Female