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

Model Number 97800

Device Problems Intermittent Continuity (1121); Energy Output Problem (1431)

Patient Problems Incontinence (1928); Nausea (1970); Device Overstimulation of Tissue (1991); Pain (1994); Dizziness (2194); Anxiety (2328); Discomfort (2330); Malaise (2359); Sleep Dysfunction (2517); Insufficient Information (4580)

Event Date 06/06/2022

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient's incision site still hurts.The patient stated that it started hurting "maybe" on the day of implant or the day after and it hasn't let up.The medication they had been given for pain had made them sick/nauseous so the patient couldn't take the medication.They had taken tylenol and ibuprofen instead.The patient also mentioned that while they were "definitely" getting a 50% or greater reduction in their symptoms (they'd only had 2 accidents since implant,) that they put it "way down" to 0 v when they slept because it had been bothering them at night to sleep and that they had the stimulation level at "probably".1 v during the day.The patient mentioned they had a follow-up appointment with their healthcare provider (hcp) on (b)(6) 2022; however, patient services reviewed with the patient to follow up with their managing hcp prior to this appointment about their concerns about healing and for advice on managing their pain.The patient confirmed that they would reach out to their hcp.The patient could not provide their serial number for their ins and they were not yet registered.The patient stated they'd received a recharge free implanted system; however, it could not be determined what ins model they had at the time of the call.Additional information was received from the patient.They reported they were still having accidents.When first asked if they were getting a 50% reduction in symptoms, the patient said they were sure.Then at the end of the call, they said they were getting a 50% reduction, they were just having accidents they did not think they should have.When they increased stimulation too high the stim sensation made them feel nervous.The patient said they tried to turn stimulation down but they were not sure if the device was working.They said sometimes the device worked and sometimes it did not.The patient said they turned stimulation off at night and they were having accidents.They said the implant site still hurt once in a while.They had an appointment scheduled for (b) (b)(6).It was reviewed how to change programs and the patient was able to change programs and increase stimulation to a comfortable level.

Manufacturer Narrative

Date of event: date is estimated; month and year are 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.

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 called back and repeated the same information regarding feeling nervous since they received the implant.They said they did not feel good with this thing.They felt nervous or something, woozy, could not sleep well and were not eating well.The patient said they had switched programs, however, that had not affected how they felt.They had decreased the stimulation setting as well and that had not made a difference either.The patient confirmed they had an appointment to see the healthcare provider (hcp) on (b)(6).The option of turning therapy completely off was reviewed, which the patient decided they would like to try.Navigation basics were reviewed and the current setting was at the lowest setting.With instruction the patient successfully turned therapy off.They were to monitor and track symptoms and to provide an update to the hcp at the ap pointment and encourage the hcp to contact the manufacturer for any additional resources to investigate the patient's reporting further.

Event Description

Additional information was received from the patient.They reported that they continue to have more accidents than they think they should, especially at night.Patient was concerned that it may be related to the charging frequency of the handset.Reviewed the two are independent of each other.Reviewed general expectations about handset charging frequency.Recommended patient turn handset off between uses.Assisted patient with increasing stimulation until they could feel it comfortably.

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.

• Brand Name: INTERSTIM X
• 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: 14743494
• MDR Text Key: 301760938
• Report Number: 3004209178-2022-07836
• 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,Followup
• Report Date: 10/11/2022

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: 10/28/2023
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 06/20/2022
• Supplement Dates Manufacturer Received: 06/20/2022; 09/13/2022
• Supplement Dates FDA Received: 07/01/2022; 10/11/2022
• Date Device Manufactured: 04/29/2022
• 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: 69 YR
• Patient Sex: Female