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

Model Number 3058

Device Problems Overheating of Device (1437); Inadequacy of Device Shape and/or Size (1583)

Patient Problems High Blood Pressure/ Hypertension (1908); Inflammation (1932); Pain (1994); Skin Irritation (2076); Swelling (2091); Burning Sensation (2146); Discomfort (2330); Complaint, Ill-Defined (2331); Numbness (2415)

Event Date 09/10/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient regarding their implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.A week prior to initial report, the patient had their bandages taken off and was told it looked good.Now, the patient feels like the ins site is bulging and it is bothersome to them; they want to know what to do.They also reported that two of their toes on their right foot are going numb.They told their healthcare provider (hcp) about the issue and was instructed to turn off stimulation which they have done.As a result of what was reported, the patient was advised to follow up with their hcp.When asked for an event date, the patient said the toe issue occurred 2-3 days after implant.The bulging was noticed the day before initial report.Healthcare provider (hcp) responded to a letter.When asked what actions/interventions were taken to resolve the bulging/numb toes and if the issue was resolved, the hcp said they decreased amplitude and changed programs.The hcp also clarified that the bulging was post-op swelling.Additional information was received from a consumer indicating that the patient felt numbness in their middle two toes, they felt like those toes were asleep for a couple of weeks.During the call it was confirmed that the therapy was off.The caller also reported that the ins bulges out and it had been this way since implant.Additional information received from the patient who noted they are in pain and the ins is bulging.They added that the pain is getting worse and their blood pressure is very high as a result of the pain/other issues.The patient called asking for help in finding a different hcp.They added that the device works great when it works, but they need someone to help them with the device.The consumer noted the hcp is not in their area anymore so they went to the old urology department a couple weeks ago.The patient told their hcp to make an appointment with the manufacturing company, but they said "let's not deal with [the manufacturing company]"; nobody looked at their device.The consumer came in for an appointment with a urology, but didn't have their patient programmer (pp) so the device couldn't be checked.The patient was driving at the time of the recent report and further reported a burning pain around it.The patient lastly noted that they want the device out if they can't get the issue resolved.They were redirected to their hcp.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer indicating that the implant site was bulging, and that it felt inflamed and irritated.The patient stated in the beginning when it was first implanted, they had pain, but it went away as the healthcare provider said it would.The patient reported the pain was back and it had intensified since (b)(6) 2019.No further complications were reported.

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

Additional information was received from the patient.They reported that the device was bulky.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8964644
• MDR Text Key: 156652603
• Report Number: 3004209178-2019-17002
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2020

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: 01/14/2020
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/13/2019
• Initial Date FDA Received: 09/05/2019
• Supplement Dates Manufacturer Received: 09/03/2019; 10/20/2020
• Supplement Dates FDA Received: 09/16/2019; 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR