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

Model Number 3058

Device Problems Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Environmental Compatibility Problem (2929)

Patient Problems Device Overstimulation of Tissue (1991); Discomfort (2330); Electric Shock (2554)

Event Date 02/05/2022

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the reason for the call was that the patient had surgery to have their left hip replaced on (b)(6) (no allegation related to device/therapy).They reported they turned their ins off for the surgery, but when they turned the ins back on following the surgery, their therapy was not helping them at all.The patient reported due to this, they switched to the last program (program 4), and reported "it shocked me" because stimulation was too strong.They stated due to this, they just turned the ins off.They did not attempt to decrease stimulation.The patient confirmed once the ins was turned off, they were no longer feeling shocking sensation or any discomfort.The patient was walked through checking their therapy setting on the call.They initially stated the programmer would not power on, but this was resolved by replacing the programmer batteries.They stated therapy was off, and when they turned therapy on at 3.7 volts, program 4 during the call, they got shocked.They turned therapy off, decreased stimulation to a comfortable setting, and turned therapy back on.The patient was then was able to increase stimulation to a comfortable setting where they were not getting shocked.The issue was not resolved through troubleshooting.It was confirmed stimulation was in the bicycle seat area and comfortable.The patient would maintain the stimulation level and continue to track symptoms.They were redirected to their doctor if the issue persisted.The patient mentioned they had an upcoming healthcare provider appointment in a couple months.

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 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: 13905415
• MDR Text Key: 297812183
• Report Number: 3004209178-2022-03808
• 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: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2022
• Date Device Manufactured: 04/11/2018
• 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: 75 YR
• Patient Sex: Female