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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Overheating of Device (1437)

Patient Problems Incontinence (1928); Burning Sensation (2146); Confusion/ Disorientation (2553)

Event Date 10/25/2022

Event Type  malfunction  

Event Description

Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that pt was confused and confusing to speak with.Initially, pt requested assistance to use their programmer saying the on button did not do anything and the off button turns it on.Troubleshooting offered to assist pt to use their programmer.Initially pt reported seeing poor communication screen but after repositioning the antenna and trying with and without the antenna attached pt was successful to sync with the ins and reported program 2, 0.9 stim was off but pt said they were not sure how it could have been off.Pt turned stim back on and stated it feels like it is getting warm they feel some "heat to it" and clarified they feel the warm/ heat where the ins site is located in their upper right buttock.At this point pt reported they had been in a car wreck yesterday, they were not injured, but they jolted against the seatbelt.Asked pt to see what happened when they could turn stim off and pt reported the heat/warm feeling went away.Recommended pt call their doctor and tell them about the car wreck/seat belt and when stim was turned on they felt warm at the site and if the doctor advised to turn stim back on they could call back and we can help them again.Pt said they had been back to pads again.Pt said they would call their doctor.

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

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.They reported that pt said they got the letter and were delayed calling about or sending back the answers to the questions because they recently got diagnosed with alzheimer's and has to go for therapy for it every so often and has all these people coming to their house.Pt provided the questions and their answers.Patient stated the motor vehicle accident did not affect the device or therapy, but also said they didn't know if it made it worse or not.Patient stated that the stimulation turned unexpectedly off was no, they do not think it was caused by the accident, it happened before they had the accident.They saw dr (b)(6) (asked/unk date).Pt said, the doctor asked if they had been using their cream, but they had forgotten to use their cream, m, w, f: they hope, since they started using it again, that will resolve the issue.Pt does not know what the c ream helps with.Pt said they put in vaginal area 3 times a night and that is supposed to help.The cause of the heating at the ins site was not determined.Pt also said when they stand up it just flows out, they go through a big container of pullups.

• 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: 15691231
• MDR Text Key: 302722410
• Report Number: 3004209178-2022-14150
• 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: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 10/28/2022
• Supplement Dates Manufacturer Received: 02/03/2023
• Supplement Dates FDA Received: 03/01/2023
• Date Device Manufactured: 03/19/2018
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 68 KG