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

Model Number 97800

Device Problems Unintended Collision (1429); Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Insufficient Information (3190)

Patient Problems Undesired Nerve Stimulation (1980); Urinary Frequency (2275); Peripheral Nervous Injury (4414); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id tm90q0 lot# serial# (b)(6).Product type accessory product id 978b133 lot# va2rxus.Implanted: (b)(6) 2023.Product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 978b133, serial/lot #: (b)(6), ubd: 17-aug-2024, udi#: (b)(4).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.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that the communicator will not fully charge.Patient said that they charged it for 3 hours the night before and it still would not charge the following night.Patient mentioned that the green light comes on but when they unplug it the yellow light comes up.An email was sent to the repair department to replace the device.Additional information was received on 2024-mar-14, the patient called back and was seeing 'not found' on the replacement communicator.Patient services had the patient toggle the bluetooth off and back on, checked that location was on and then turned airplane mode on and then off again and the patient was able to then switch communicators in the application from the 'not found' screen and the communicator successfully paired to the handset.External devices were functioning as intended.The patient was then able to connect to see their settings.The patient then stated "i'm gonna turn it up because i've been peeing a lot." they also stated they were "peeing real weird." the patient further clarified that it began after they "fell real hard" on their tailbone two weeks ago.Patient stated they had been on program 4 and it worked so well for their symptoms but then they fell and their symptoms returned and now also the nerves down their legs have been affected.Patient stated they thought something must be wrong with the wire especially when the communicator wasn't working yesterday.Patient stated that yesterday, they had been meeting with two manufacturer representatives at the health care provider (hcp) office because they were going to check the implanted system since the fall but they had the communicator mishap.Since the fall, they had the thing with their nerves down their legs and their left foot was "like a drop foot".The patient stated that they went to their spinal surgeon after they fell and the spinal surgeon did an x-ray and told the patient that their spinal surgery looked fine and told the patient "you fell straight on your tailbone." the patient stated they gave them a disc of the x-ray to take to their hcp appointment yesterday with the reps but the reps told the patient they couldn't read the disc and that the patient would need to bring a film.The patient stated the rep wanted the patient to get another xray on film of the lead and bring it back to review but they also told the patient they thought the implanted system was "probably fine." the patient stated the other rep was telling them they could switch them to program 6 but the patient didn't want to leave program 4.They stated the rep katie asked them if they were still using the vaginal cream their hcp prescribed them in 2020.Patient stated they never used it and that they were supposed to have put it around their vagina and asked patient services if patient services could check to see if it was ordered by the rep again.Patient services reviewed the role of patient services and the rep and redirected the patient to continue following up with their hcp about their symptom concerns post fall.Patient increased their stimulation on program 4 to comfortable level where they felt the stimulation in their "behind" and they were going to monitor their symptoms and get another x-ray on film, bring it to their hcp office and continue following up with their hcp.They were mainly upset with themselves for falling in the first place and "causing all of this.".

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.

Event Description

Additional information was received.Patient called back in regards to their fall which was already reported.Patient states they now would like assistance with turning the therapy back on.Patient stated the doctor said the patient could do this as soon as they felt comfortable.Agent walked patient through turning stim back on and patient confirmed it's comfortable and in bike seat.

• Brand Name: INTERSTIM X
• 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: 18932156
• MDR Text Key: 338017604
• Report Number: 3004209178-2024-07314
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: 00763000484668
• 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: 03/19/2024

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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2024
• Date Device Manufactured: 04/18/2023
• 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 Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Female