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

Model Number 97800

Device Problem Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Nerve Damage (1979); Urinary Frequency (2275)

Event Date 12/04/2023

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 patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim.The reason for call was the patient reported that since they got the implant, the therapy had not been helping their symptoms.The patient stated they were still up urinating all night and when they got up in the morning,they saw the timed out message on their handset.Patient wanted to know if that was because their ins battery was low.Agent reviewed the meaning of the timed out message with the patient and external device function with the patient and redirected the patient to their managing health care provider to discuss their symptom concerns about the therapy not helping.The patient stated they had been working with medtronic representative (rep) since "pretty much the beginning" and that the rep knew that the therapy would help the patient for a day or 2 but then it would quit helping.The patient stated the rep had the patient switch from program 1 to program 2 and the patient stated they thought program 2 had helped their symptoms but then the rep told them just a few days ago that program 2 would drain the ins battery faster so they told the patient to go back to program 1.The patient stated they were back at program 1 again and at 4.7 ma but they were up 15 times last night.The patient stated it was taking a toll on them with their anxiety and depression and they wanted to find a setting that could help their symptoms.Patient services reviewed device description function as well as programming and stimulation considerations.The patient stated they'd never felt anything when it came to stimulation on program 1.The patient stated that they were told going into getting the implant that their nerves were "so messed up" by their spine, that they had a lot of nerve damage, and because of that, during the procedure it took them a long time to "connect everything." the patient asked if the reason it wasn't helping was because it wasn't connected right/there was something wrong with the way the therapy was set up.Agent redirected the patient to talk about their concerns with their managing health care provider (hcp).The patient stated when they were on program 2 they did feel an "itchy" sensation in their bike seat and that program 2 worked just fine for them so they didn't understand why they couldn't use program 2.Patient stated they were going to just increase the stimulation on program 1 and monitor their symptoms for now.Agent emailed the rep to advise them of the situation but redirected the patient follow up with the hcp regarding their concerns and to further address the issue/locate a good program setting.

• Brand Name: INTERSTIM X
• 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: 18560768
• MDR Text Key: 333434083
• Report Number: 3004209178-2024-01708
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: 00763000484668
• 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: 01/23/2024

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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 01/23/2024
• Date Device Manufactured: 10/09/2023
• 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 Age: 68 YR
• Patient Sex: Male