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

Model Number 97810

Device Problems Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583); Unstable (1667); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

Event date is approximate.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was first received december 1, 2020 from a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence and gastrointestinal/ pelvic floor.It was reported that patient saw the doctor yesterday.They tried to recharge today.They locate the device and then loses the connection right away.At first they didn't find the stimulator at all, then it established excellent connection and then it went to device not found, to call manufacturer.Patient talked to the representative in florida who advised them to take the recharger out of the belt.Patient service asked the caller if they have any emi in the room and they said no they were in their bedroom.They have tired with the belt and without.The patient has tried over the skin and over clothing.They have tried standing.Patient services had patient feel where the stimulator was and put the round circle of the recharger over the stimulator.Patient services told the patient go to the right side of the implant and wait for 30 seconds, sit down and lean forward.Patient was then able to connect with sitting, leaning forward, and to the right side of the stimulator with no belt and recharger directly on the skin.The troubleshooting steps that were taken on the call resolved the issue.Stimulator battery status was 30% and had excellent charging status.On an additional call the patient reported they have had trouble charging the ins since the 1st time.Patient said they connect w/ the ins for 5-6 seconds then lose connection.Patient said every week they charge they have this problem.Patient said yesterday ((b)(6) 2021) while charging they saw the 1707 message.Patient said they tried to charge all day yesterday.Yesterday patient was charging in their living room.Patient said they were near the tv, tablet and cell phone.Patient said the tablet was closed.Patient was sitting while charging yesterday.When patient called in the patient was in their bedroom.Patient and husband were both on cell phones.Before putting recharger on ins patient saw a 4100 code.Patient put recharger on ins lining up the circle over the ins, recharger connected for a moment then went to searching.Patient stood up and moved the recharger down a little bit and was able to connect to the ins and maintain the connection while holding the recharger in place w/ their hand.Patient charged from 50-60% during the call and still had connection at the end of the call.Patient said when they have tried to use the belt they have had problems.The patient called back saying it takes them hours to charge the ins.Patient said the recharger connects to the ins for a moment then goes back to searching.Patient has tried to charge the ins for the past 2 days and the ins hasn't charged.Patient said normally when they charge the ins after 6 days the ins is down to 60% but today after 6 days the ins battery level shows 80%.Patient services reviewed repositioning the recharger for the ins, patient was able to connect for a moment then saw code 1707.Patient said they are not able to feel all four sides of the ins.Patient said the ins does not feel like a rectangle.Patient said the ins feels like a triangle and they can feel one small point.Patient has not had any in person troubleshooting w/ the recharger.After troubleshooting patient was not able to start and maintain a charging session.Recommended patient follow up w/ hcp to schedule an appointment for in person troubleshooting.2021-sep-24 additional information was received from a consumer via a manufacturer representative.It was reported that the patient saw an error code 1707.The patient couldn't connect and had tried multiple positions.The caller was not with the patient.Technical services reviewed that this code meant to reposition the wireless recharger.It was also noted that the patient doesn't charge with the belt, because they couldn't recharge successfully with it.The patient's work around was to charge without it, but no other information was provided regarding this issue.The patient was out of town and planned to meet with the rep on (b)(6) 2021.It was noted that the patient had not lost/gained weight or experienced any trauma.2021-oct-08 additional information was received from the healthcare professional via the rep: the cause of the difficulty maintaining connection to recharge determined to be due to the battery is moving/flipping in the pocket site, the implant location likely cont ributed to this issue.Patient was evaluated by testing md and nurse along with mdt representative.The micro battery was movable in the pocket.Patient is still unable to recharge the device.There was no weight gain or loss since implant.Device is located in patient's upper buttock on the right side but unable to give exact depth of device.The rep also attempted to get capture of device with recharging disc and belt with no success.Patient to have consultation with implanting md to discuss pocket revision versus replacement with recharge free device.

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 a manufacturer representative (rep).The rep reported that the rep was uncertain if depth was a concern.The patient denied any falls/trauma or dramatic weight loss/gain.The ins was not located in the fold of the skin and twiddler's syndrome was not suspected.The patient had a surgical consult on friday (b)(6) 2021 and had decided to hold off on the pocket revision until after the first of the year due to an insurance change.The patient was going to reach out once their new insurance had taken affect.

• Brand Name: INTERSTIM
• 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: 12614695
• MDR Text Key: 275895135
• Report Number: 3004209178-2021-15204
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000203849
• UDI-Public: 00763000203849
• 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,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

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: 02/28/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 11/11/2021
• Supplement Dates FDA Received: 11/16/2021
• Date Device Manufactured: 09/08/2020
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female