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

Model Number 3058

Device Problems Electromagnetic Interference (1194); Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Overheating of Device (1437); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Pain (1994); Burning Sensation (2146); Urinary Frequency (2275); Discomfort (2330)

Event Date 05/17/2023

Event Type  malfunction  

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

Information was received from a healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that caller is from mri center where patient (pt) was to have a thoracic spine scan today.They were using built-in "d stream spinal coil built into the table (receive only) and transmitting from main body coil and a phillips machine.Mri center staff viewed pt putting their ins into mri mode and pt was showing as being full body mri eligible per caller.They put pt into the mri and did first survey scan which was about 27 seconds long.Pt later said they felt warmth during this time but didn't say anything.They started the 2nd survey scan and stopped it a little over halfway from being done (it would have also been 27 seconds long if completed) because pt had started moving around and reaching back to their right hip and then pt reported their ins pocket area feeling very warm.They stopped scanning and pulled pt out of the machine. pt mentioned to caller that pt had prior history of putting their device into mri mode and "bouncing out" of mri mode without doing anything. the radiologist palpated the pocket area and this felt tender and painful to the pt.Pt feels like their ins changed position so that it's not in the usual pocket area and tight in the pocket but now pt could move the ins around under the skin in their hip area.Pt tried connecting to their ins using handset but wasn't able to.There was no error from what caller understood from pt, just that they were unable to connect.They were using 1.5t machine and using a program that downloads the mri "fda" settings to the mri machine.Caller looked at the summary of the scan settings and shared the following maximums that were programmed into the machine: spatial gradient 20 t/m, max slew rate <(> <<)>200t/m/s, normal operating mode, sar level of <(><<)>2.0 w/kg.Managing hcp and caller spoke with p.A.Who works with hcp and they instructed pt to go home and then they were going to make a follow up appointment to see pt.Caller was told by pt that pt was now concerned because with their stimulation off, they would be having to go to the bathroom every 5 minutes.Pt having some type of surgical procedure in about 2 weeks (reason for mri).Caller doesn't know if surgery is related to ins system.

• Brand Name: INTERSTIM II
• 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: 17118638
• MDR Text Key: 317274505
• Report Number: 3004209178-2023-10733
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000449711
• UDI-Public: 00763000449711
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2023
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• Date Device Manufactured: 11/10/2021
• 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
• Patient Age: 42 YR
• Patient Sex: Female