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

Model Number 97810

Device Problems Energy Output Problem (1431); Overheating of Device (1437)

Patient Problems Burn(s) (1757); Insufficient Information (4580)

Event Date 04/09/2024

Event Type  malfunction  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence and urin ary/bowel dysfunction.It was reported that sensations occurred while recharging during today's call.The following troubleshooting steps were performed: recommended using recharger over a thin layer of clothing.Patient was using the belt, which was then placed over their pants.This did not resolve the issue.Reviewed, however, the patient said he really isn't concerned as long as he is able to recharge the device.Please note that the patient is very thin, 90 lbs., due to the medical condition of gastroparesis.Additional information was received.Since receiving the implant every time she uses the communicator, has experienced a burning/stinging sensation at the neurostimulator site but also increased stimulation sensation by 80% in the vaginal area (right vaginal lip) and then increased symptom results.When asked, the patient said that it just connects to the implant when experiencing this change.The patient said they experienced these increased sensations the whole time that the communicator was over the implant and connected to the implant, and as soon as they removed the communicator, these sensations stopped.The patient said they would like to know if they should keep the communicator over the site more since therapy works better during this time.The patient would like to know why there is an increase in sensation in the vaginal area.When asked, the patient said they typically just place the communicator over their underwear.The patient mentioned that they have gastroparesis(unrelated) and other medical conditions, are very thin (90 lbs.), and can visually see all of the implanted components in their body.The patient said he mentioned it to the physician and was redirected to a representative; however, arrangements to troubleshoot in person haven't occurred.Potential notification date: end of november 2023.The patient said she was redirected to contact patient services.The patient connected during the call and confirmed increased stimulation sensation in the vaginal area and stinging/burning sensation at the neurostimulator site as long as the communicator is over the neurostimulator site and connected to the implant.During the call, the patient placed an additional layer of clothing over the site and tried connecting after experiencing the same increased stimulation sensations.The issue was not resolved through troubleshooting.Patient services will contact technical services for additional guidance on the next steps and then follow up directly with the patient.

Manufacturer Narrative

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: 19114781
• MDR Text Key: 340939087
• Report Number: 3004209178-2024-09138
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2023
• Device Model Number: 97810
• Device Catalogue Number: 97810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2024
• Date Device Manufactured: 06/07/2022
• 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: 61 YR
• Patient Sex: Female