MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Model Number 3058

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problems Incontinence (1928); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2022

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient had their ins battery replaced due to normal battery depletion.The patient stated it had been working great until the battery had died.Since the patient's interstim was placed, they had worked with a healthcare provider (hcp) on having an abbott pudendal nerve stimulator placed.When the interstim ins was replaced, the doctor had pulled the leads loose away from the abbott pudendal nerve stimulator.It was reported that the abbott stimulator's indication for use was not related to the interstim ins's indication for use.The patient stated it had taken them a while to find the doctor that did the replacement and that their initial implanting hcp for their first interstim ins did not want to attempt to replace the interstim battery or see the patient any longer so a representative from abbott spoke to a manufacturer representative (rep) (patient did not know this rep but through emails and did not know their name) who had referred the patient to another interstim doctor.The patient stated from the way they understood it, as a result of what was done at their ins battery replacement surgery, "the system" hadn't been "intact" and the "leads were crossed over each other." the patient then brought up their abbott doctor again and stated the doctor "is an awesome doctor" and helped the patient with the right side of their body but then the patient had pain in their "left groin, not groin but left leg and it feels like those bladder spasms and i could be sitting there doing nothing and have no bladder control." patient services documented what the patient stated but did not ask further questions about the comment as the patient was reporting a lot of information and patient services was doing their best to document and keep track of the patient's timeline.The patient stated just 4-5 weeks ago, their abbott doctor had to go in and "reattach the wires" for the abbott stimulator and that they were having "a whole lot of pain"; that they were always in pain.Patient services did not ask further questions about the pain as they were focused on the reason for call.The patient stated they needed to find a rep to help them because they needed a hcp to talk to about their concerns about the interstim device and their abbott doctor didn't know anything about the interstim ins.Patient services reviewed the role of a rep with the patient and offered to send the patient physician listings so they could locate an hcp to assist them with their issue.The patient stated in their previous search for an hcp to do the replacement, some doctors didn't want to work with them, and the patient stated they didn't understand why because the two systems were 6 inches away from each other, but that they'd reach out to an hcp on the listing.Patient services also emailed the field to alert them of the situation.The patient's relevant medical history included the patient stated that prior to getting the interstim system implanted, they had a vaginal mesh that broke away and migrated into their organs and muscles and that was how they "ended up with these problems" (that required them to get the device/therapy.) the patient stated they also had an scs spinal cord stimulator but they did not name the name of the manufacturer of that device.

Manufacturer Narrative

Section d references the main component of the system.Other medical products in use during the event include: brand name interstim; product id 3093-28 (lot: va07d5h); product type: 0200-lead.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

It was noted the lead or ins had been implanted past the use-by date (ubd).

Manufacturer Narrative

Continuation of d10: product id: 3093-28, lot#: va07d5h, product type: lead.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.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 17550159
• MDR Text Key: 321224275
• Report Number: 3004209178-2023-14288
• 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: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2014
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 08/29/2023
• Supplement Dates FDA Received: 09/05/2023
• Date Device Manufactured: 03/20/2013
• 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 H10...
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female