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

Model Number 3058

Device Problems Intermittent Continuity (1121); Energy Output Problem (1431); Communication or Transmission Problem (2896)

Patient Problems Abdominal Pain (1685); Device Overstimulation of Tissue (1991); Urinary Frequency (2275); Discomfort (2330); Urinary Incontinence (4572)

Event Date 06/06/2023

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.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 gastrointestinal/pelvic floor.It was reported that they were having an issue with their handset, they thought.Patient said for the past 2 days, they had been having urinary incontinence again which was unusual for them with the stimulator and they were experiencing a fluctuation in amplitude throughout the day.Patient said that they usually go to the bathroom maybe 3 times a day, morning, afternoon and night and now they were going 25 times a day.Patient stated they were always on the same program (program 4) at the same amplitude (2.0ma) but they increased stimulation (stim) to 2.2ma due to therapy issues and it hadn't helped.Patient said they didn't want to increase it too much because when they notice the amplitude was fluctuating on it's own and went too high, they would feel a pinching pain in their bladder.Patient said they had never had telemetry issues but when they started to experiencing the stim pain, they weren't able to connect to their implant right away and kept seeing "device not responding".Patient confirmed they were using communicator correctly.Patient said eventually they were able to connect to their ins but not while they were feeling the stim pain.Patient said they lost their handset in their house and these issues seemed to start once they found it again 2 days ago.Patient said they never usually had to use their external equipment because they didn't usually have any therapy issues.Patient confirmed no falls/trauma/procedures and also said they were always sitting because they can't walk so overstimulation was not present during different positional changes.Patient was sure the handset was providing fluctuation in amplitude and said that when they do connect to their ins, the amplitude was still set at what patient had it on.Patient services reviewed "device not responding" and that devices seemed to be working as intended, as they were able to power them on, access therapy applications and connect to ins.Patient services explained that a new handset may not fix this issue and recommended patient see their healthcare provider (hcp).Patient services sent email to repair and told patient they will need to get handset reprogrammed by hcp or manufacturer representative (rep).Patient services emailed field staff to notify of situation, as patient said their managing hcp is 1.5 hours away and they were not able to go far for in-person programming.

• 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: 17255584
• MDR Text Key: 318656441
• Report Number: 3004209178-2023-12083
• Device Sequence Number: 1
• Product Code: EZW
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/05/2023

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: 08/14/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 07/05/2023
• Date Device Manufactured: 02/24/2021
• 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: 53 YR
• Patient Sex: Female