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

Model Number 3058

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Bruise/Contusion (1754); Incontinence (1928); Pain (1994); Urinary Frequency (2275); Discomfort (2330); Complaint, Ill-Defined (2331); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/04/2020

Event Type  malfunction  

Manufacturer Narrative

Event date is approximate (year valid).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 fecal incontinence and gastrointestinal/pelvic floor.It was reported that the patient thought the battery had moved around and shifted to the surface.At first, they thought it was a pocket of infection, but now they did not think it was an infection; they thought it was the battery itself and that it had not settled in.They thought it would get better.They went to the dermatologist, and they said it looked like a bruise.It was still really tender.It had started to ache and kind of hurt. they wanted to know if the lead was long enough if the ins had moved that it wouldn't make the lead move from the proper location. they stated they received the implant for their bowel, but it did not hold like before.They weren't leaking like they were before, but it was more pebbly and it wasn't like this before they had the issue with the ins.It seemed to affect the bladder too, and they wanted to know what to do so it did not affect their bladder also.It was explained the therapy could affect both bladder and bowel.They had to urinate more often, and were waking up 2-3 times a night.All of these issues, the ins shifting to the surface, bowel, and bladder issues, were stated to have started about a month to three weeks ago.The patient was redirected to their healthcare provider to further address the issue.

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 healthcare provider (hcp).It was reported that there is a scheduled ultrasound to evaluate the issue.No more further actions are planned as of now.

• 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: 10803103
• MDR Text Key: 219995347
• Report Number: 3004209178-2020-19513
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

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: 07/28/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 12/03/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 90