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

Model Number 97810

Device Problems Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)

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

Event Date 09/02/2021

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that they were getting 1707/coupling issues error.The following troubleshooting steps were performed; apply comfortable pressure to the recharger or consider tightening the recharging belt, recommended patient lean forward while sitting to optimize ins position, recommended using recharger over a thin layer of clothing.The patient (pt) reported they were unable to keep recharging and stated their recharger loses connection with their implant.Pt stated they tried for a couple hours off and on yesterday and was able to charge 10%, but reported they were getting a "all sorts of messages".Pt stated today they were able to charge up to 70%, but stated they had to reconnect to charge over and over again and reported getting 1707 message.Reviewed message meaning.Walked pt through charging ins on call and reviewed recharging best practices.Pt confirme d connected to charge and was charging with excellent connection.Pt stated ins charged from 70-80% during call.Pt was sitting while charging on call.Reviewed consideration to lean forward or cross leg.Pt reported the belt doesn't work for them.Pt stated they position the recharger over their ins leaning against something and that applies pressure.Pt stated they don't move and that has been working to charge until this issue started yesterday.The troubleshooting steps that were taken on the call resolved the issue.No patient symptoms were reported.Additional information was received from the patient.They reported ongoing difficulties charging the ins and maintaining a charge.Patient repeatedly encounters 1707 code as well as 3604 code every time they recharge their ins despite resetting the recharger.Patient services reviewed meaning of code and emailed replacement recharger request to repair.Reopened case to add replacement recharger sn to secure note.The patient called back and reiterated previously reported information.They stated they had been having more and more trouble connecting when charging and that it was so frustrating.The patient stated it would show excellent connection and then go back to searching.Patient stated it took them 40 minutes to go from 40% to 70% charge and so they would give up and try again the next day and then it would take another 40 minutes to go from 70%-100%.The patient stated they could see if they'd lost a bunch of weight having trouble like the people they saw online where the ins would move but they hadn't lost a bunch of weight and they could feel the ins under the skin and it was in the same place where it had always been since they got it and flat and level with the surface of the skin.Patient services did not ask any further questions about this comment as they were focused on the reason for call.The patient stated they also received an open loop charging screen when the ins was at 70% and they'd never gotten that before this week.The patient also reiterated that they would get a 1707 service code.Patient stated they always got that code many times while trying to charge.Patient services reviewed the meaning of the 1707 service code and reasons for why they'd see the open loop charging screen.The patient stated they were sitting in an electric lazy boy chair.Patient services reviewed the presence of metal in the chair and potential emi could be interfering with the charging and recommended the patient move away from such sources.Patient then tried a session at their computer chair and still got an open loop charging screen.The patient was then able to see the closed loop charging screen and at this time, the patient stated the ins just went from 80% to 90% charge and stated they just charged and they didn't charge but every two weeks so they couldn't figure out why it was al ready down to 80% charge just now.The patient also noted they heard the recharger making a clicking sound which they hadn't noticed before.Patient services reviewed with the patient to make sure to try to charge away from the computer and all sources of interference which should resolve the open loop charging screen but if they continued to get the 1707 to follow up with their health care provider (hcp) especially if they felt that the ins battery was draining more quickly than they would expect.The patient stated they would keep an eye on the implant charge level.They also noted it was hard to find a comfortable position to be in to keep the recharger in one place to charge the ins if not their lazy boy chair.They stated the belt just didn't stay right so they couldn't use it.Patient stated it wasn't that the belt didn't fit but if it was too loose, it was "slippery" and that making it too tight that recharger didn't move made it hard to breathe.Patient stated the 1707 was something they'd consistently get however so if they contin ued to get it after trying a new area to charge in, they stated they would follow up with their health care provider (hcp) to check the implanted system.Patient stated they were now seeing a new hcp at the same clinic as their previous hcp.Patient services also sent an email to device registration to update the patient's record.2 call recordings.

Manufacturer Narrative

Continuation of d10: product id wr9220 serial (b)(6) : product type recharger product id wr9220 serial (b)(6) : product type recharger product id wr9220 serial (b)(6) : product type recharger 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: INTERSTIM
• 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: 18992847
• MDR Text Key: 339249165
• Report Number: 3004209178-2024-07987
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2022
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2024
• Date Device Manufactured: 01/20/2021
• 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
• Treatment: "SEE H11...."
• Patient Age: 62 YR
• Patient Sex: Female