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

Model Number 97800

Device Problem Energy Output Problem (1431)

Patient Problems Pain (1994); Urinary Frequency (2275); Discomfort (2330); Hematuria (2558); Insufficient Information (4580)

Event Date 10/23/2023

Event Type  malfunction  

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/bowel dysfunction.It was reported that since received this implant on (b)(6) 2023 has experienced a lot of discomfort right at the neurostimulator site.Patient said that last month was in severe pain and saw their urology surgeon.Patient also said that noticed blood in the urine and a culture was ran which came up negative.Patient said turned stimulation off about two weeks ago.Patient also said was urinating all of the time since turned stimulation off.Patient said that the blood in the urine stopped and the pain at the neurostimulator site has also stopped.Patient said that their urologist's office redirected patient to contact medtronic for direction.Later in the call asked about any changes and patient said that around the first of the year they stopped taking bladder medication, gemtesa due to insurance reasons.Patient then said that has been taking gemtesa since received this implant and beforehand.When asked, patient said will be restarting gemtesa in a day or two.With instruction patient connected to implant and it was determined that stimulation was on, which means that patient didn't turn therapy off before when they thought they did.Patient then mentioned that turned therapy down.Reviewed general programming guidance and patient made a slight increase in setting.Patient to monitor bladder symptoms however to also pay attention if notices any discomfort at neurostimulator site.Patient to keep stimulation setting the same after restarts bladder medication and wait a few days to determine results with medication.If needed, patient to make slight adjustments to setting and continue to monitor bladder symptoms and whether or not notices any discomfort at neurostimulator site.Suggested patient provide update to urologist.

Event Description

Additional information was received from the patient.They reported that the cause of the stimulation being on when it was noted that it was off is unknown.They were experiencing pain where the device was placed and the doctor said it was off.It was when they talked to the manufacturing representative (rep) and was told it was still on, but they had turned it off.The rep went over it with them.They really don't think their device is working as it should because they are still having problems.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18883509
• MDR Text Key: 337468921
• Report Number: 3004209178-2024-06835
• 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,Followup
• Report Date: 05/07/2024

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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 05/07/2024
• Date Device Manufactured: 06/15/2023
• 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 Age: 85 YR
• Patient Sex: Female