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

Model Number 3058

Device Problems Electromagnetic Interference (1194); Overheating of Device (1437); Difficult to Remove (1528); Insufficient Information (3190)

Patient Problems Pain (1994); Burning Sensation (2146); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id 3889-28 lot# va1mqyr.Implanted: (b)(6) 2018.Explanted: (b)(6) 2018.Product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 3889-28, serial/lot #: (b)(6).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 patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/ pelvic floor and urinary dysfunction/sacral nerve stim.The reason for call was the patient reported they got a letter in the mail saying it was time to upgrade their battery.The patient stated they had their bladder stimulator removed years ago because they had an mri of their knee and they started to feel a small burning sensation which suddenly became excruciating and they had to hit the button to tell the mri tech to stop because it was so painful and they were clenching.The patient stated they'd never felt anything like it before.The patient stated they'd even told the mri tech they had the device but they still did the scan and it "anchored the leads" to their tailbone.The patient further clarified that the lead was burned to their tailbone and it was "kind of difficult for them to get in there." the patient stated they called their managing health care provider (hcp) at the time, however the patient no longer goes to this hcp) who got them in to remove it "on the spot" a few days later.Asked the patient if they had any specific dates on when the device was removed or when the event occurred and the patient stated, no, i don't have a date but that they would call their old hcp's office to get the date and call device registration to update them.

Manufacturer Narrative

Continuation of d10: product id 3889-28 lot# va1mqyr implanted: on (b)(6) 2018 explanted: on (b)(6) 2018 product type lead 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received from the patient.They reported that approximately 5 years ago they had to have their bladder stimulator removed.They had a routine mri being done on their right knee.At that time they felt extreme pain and burning where the lead was placed on their tailbone.They had the stimulator removed and now twice a year have to get botox injections for the rest of their life.They have a nonfunctional bladder and were only 47.They are permanent disability.They received a letter stating that there could be a possibility of a piece of the lead left in their body.They would appreciate someone contacting them in regards to this letter and possible legal actions.

• 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: 18085153
• MDR Text Key: 327542846
• Report Number: 3004209178-2023-19244
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2019
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2024
• Date Device Manufactured: 10/13/2017
• 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 H10...."; "SEE H11...."
• Patient Outcome(s): Required Intervention
• Patient Sex: Female