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

Model Number 3058

Device Problem Insufficient Information (3190)

Patient Problems Incontinence (1928); Loss of consciousness (2418); Insufficient Information (4580)

Event Type  Injury  

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

Information was received from a healthcare provider 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 ins no longer works.Caller unable to clarify further, was not with the patient at time of call.Additional information was received from the patient.The patient called back to ask about compatibility for mris, cat scans and other potential tests/procedures and referenced they were responding to patient letter.Please understand the patient was difficult to follow and patient services did their best to capture the reported information.Initially the patient stated there was not an issue with the device "not working," that the issue had been that the patient needed a procedure but they didn't have their programmer with them so the therapy was unable to be turned off.The patient stated they weren't making sense at the time because of their brain and that the doctors had been able to turn the therapy off and afterwards, the patient was able to turn the therapy back on when they were home.Patient services reviewed with the patient to have their programmer with them from now on so if the therapy needed to be turned off, it could be turned off.The patient then stated contradictory information to what they previously said about the device not working.They reported the hcp who implanted their system was no longer at the practice and they were seeing another urologist in (b)(6) and that the therapy had helped for "maybe a year" but then it stopped working/stopped helping them and their symptoms got "worse and worse" and they were having to wear depends and change them a couple times a day it was "so heavy." the patient stated when they saw the urologist in (b)(6), the urologist was surprised to find that the therapy had been implanted before the patient had been given medication or "shots" first so that urologist did a "way better" test and gave the patient medication first that made their mouth dry.Then they were given a "shot" in their kidney.The patient stated it wasn't botox, but something that started with a "bur.Something".The patient stated the shot "worked" until they had to go have their brain "worked on" and they also put a catheter in but that now they were having a "little leakage again".The patient stated they needed to go see a different doctor now about their liver.The patient stated they still used the therapy in addition to everything else, and stated they couldn't have the stimulation too high because it would make them "pass out".The patient then clarified that they were very sensitive to pain so they had to keep the stimulation at a lower level and then stated they believed "the reason" their symptoms were the way they were and the reason their kidney was acting "a little crazy" (which in turn made the implanted system "act a little crazy") was because of their "brain itself." the patient stated that sometimes they made sense of things and other times, their brain caused them to say things that didn't make sense.The patient also reported having muscle pain.The patient stated their weight at the time when they needed to have their procedure had been 155 pounds and that after their brain surgery they got down to 144 pounds but they were now back to 150 pounds.Patient services offered to send the patient physician listings so the patient could find a doctor who worked with the device/therapy but the patient declined the offer.

• 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: 16751198
• MDR Text Key: 313405405
• Report Number: 3004209178-2023-05093
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2023

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: 05/28/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/17/2023
• Date Device Manufactured: 11/29/2018
• 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 Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 68 KG