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

Model Number 97810

Device Problems Failure to Deliver Energy (1211); Use of Device Problem (1670); Malposition of Device (2616); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Incontinence (1928); Pain (1994); Discomfort (2330); Sleep Dysfunction (2517); Insufficient Information (4580)

Event Date 11/17/2021

Event Type  malfunction  

Event Description

Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence and gastrointestinal/ pelvic floor.It was reported that the patient's incision site was still sore.There were no device issues nor further patient complications reported at this time.Additional information was received from the patient.They reported that they wanted coaching on recharger placement, and stated it was very difficult to maintain a charge connection.They were able to make an excellent connection and see their ins battery was at 60%.They stated they had to place so much pressure on their recharger to connect it to their ins, the recharger hurt their incision.The incision was not fully healed, and as they were diabetic, they were a slow healer.The patient stated they also had an insulin pump.They confirmed they recharged successfully at their hcp's office.The patient was redirected to their healthcare provider to further address the issue.An email was sent to repair to request the patient be sent a medium recharging belt, as they reported the patient had a recharging belt that was too big.Additional information was received from the patient.The patient called back and reported their issue with charging their ins.The patient stated they "couldn't connect the damn thing," that they had so much trouble when they tried to charge their ins and that they "hated" it.The patient stated by the time of the call, they'd previously scannedin the recharger a number of times but they were getting 'not found." the patient stated they were "so sorry" they picked the [device] and that when they went in for their annual, their managing health care provider (hcp) told them they weren't even recommending the [device] any longer.The patient received another "not found" message on the recharger application and the patient did a recharger reset.The patient then got a 3167 service code and dismissed the code and the recharger appeared to connect to charge the ins though the patient stated it wasn't near the ins.They said they had an excellent connection.The patient then placed the recharger over the ins site and the screen switched to connected, ins battery was at 10%, the therapy was off and the connection was excellent.The patient stated they weren't even using a belt at the time and it then went back to searching again.The patient stated they hadn't moved.Patient services recommended the patient use their belt and recommended that the patient cross a leg and lean forward to make the ins easier to connect with and the patient stated the ins was already pretty close to the surface and that they were "pretty bony." the patient was then able to connect to charge their ins again with excellent connection.Patient services reviewed for the patient to not be near any metal or electromagnetic interference when trying to charge and to be certain the communicator was off.The patient stated they didn't even know where the communicator was, that they always sat on a chair that had metal when going to charge and they were always next to a computer.The patient stated from now on they would charge away from the metal and the emi.The ins charge went up to 20% by the call's end and t he patient was going to continue charging their ins to completion.The patient stated they were going to search for their communicator and call back for assistance in turning the ins back on once the ins was charged.The patient stated they never knew they had to turn the therapy back on after they charged the ins back up after being depleted.The patient stated the ins must have been off this entire time.The patient also stated they were going to have an mri stress test in june so they were going to find their communicator to review turning their therapy on and to review mri considerations and mri mode.They later called back and stated they could not find their communicator.Email sent to repair for replacement communicator.On 2023-jun-08, the patient (pt) said after successfully charging to 100 percent last week, they were successful to turn therapy on and felt sensation.Pt said they are charging again today and had been trying for quite a while and could not make it connect.Patient services worked with pt to restart the handset and charger and move their portable insulin pump from the left side pocket to their right side pocket (pt said their stimulator was on the left side of their body) and after briefly seeing an error message (pt did not note what the message said) pt was successful to connect with an excellent connection and the ins was 40% charged therapy was on.Pt said they connected when the charger was off to the side a little bit and said the charge progressed to 50%.Patient services reviewed some recharging best practice.Patient called in to see if medicare would cover the device to be replaced w/ a non rechargeable device.Patient said the hcp told the patient they needed to find out.Patient asked for hcp listings, sent listings.Patient said the recharger will not connect w/ the ins.Reviewed how to charge.Patient was able to connect to the ins and start a charging session.Patient said it is nothing like the cute little videos.Patient said they didn't get a lot of sleep because the device doesn't work and the patient is wearing diapers.Patient was up last night changing sheets, changing themselves and showering.Reopened and reassigned case to email hcp listings.

Manufacturer Narrative

D10: product id wr9220 lot# serial# (b)(6) implanted: explanted: product type recharger product id fp9000m lot# serial# unknown implanted: explanted: product type accessory section d information references the main component of the system.Other relevant device(s) are: product id: wr9220, serial/lot #: (b)(6), ubd: , udi#: this regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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: 18932884
• MDR Text Key: 338481293
• Report Number: 3004209178-2024-07323
• 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: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2023
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2021
• Date Device Manufactured: 07/20/2021
• 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: 74 YR
• Patient Sex: Female