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

Model Number 97800

Device Problems Failure to Deliver Energy (1211); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Urinary Tract Infection (2120); Urinary Frequency (2275); Dysuria (2684)

Event Date 11/01/2023

Event Type  Injury  

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed valid.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 friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim.The reason for call was the patient rep said the patient called them this morning and told them they have a uti again.Patient rep said they were going to call the hcp tomorrow and see if they can tell them who the manufacturing representative is.The patient said doesn't feel the stimulation sensation.Patient said they did feel it when the rep set it in the operating room, but doesn't feel it anymore.Since then it doesn't seem like they feel the stim because they can't go higher.Patient used to always be at 1.0 on their other device.Patient was originally on program one.When they first got the device they started having uti's so they changed programs.On a few of the programs they can only go up to 0.5 or 0.6 and it has an excl amation mark with a circle next to it.Patient is trying to figure out what is a good setting for them to keep the utis away.Patient has been having a little more uti's since (b)(6) 2023.Patient has been urinating too much, but is not emptying their bladder.Agent asked them if there is a code that pops up.Patient rep said no there is not a code.The old device never had that where they couldn't increase past a certain level.Patient rep was not with patient so they couldn't troubleshoot.Told patient rep to tap on where the i and circle is to see what the warning is for.Agent explained to them it sounds like oor.The patient rep is going to call on wednesday and will do some troubleshooting.Patient rep doesn't know the name of the representative who was at the implant and came to the post op appointment.Agent looked up the therapy specialists and gave patient rep their names but they didn't know.Patient has a recheck in (b)(6) 2024.

• 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: 18920500
• MDR Text Key: 337855030
• Report Number: 3004209178-2024-07231
• 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: Other
• Type of Report: Initial
• Report Date: 03/18/2024

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: 02/26/2024
• Initial Date FDA Received: 03/18/2024
• Date Device Manufactured: 09/08/2023
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female