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

Model Number 3058

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Skin Irritation (2076); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 11/13/2019

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 consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that ever since the patient received the implants, when stimulation was on it jolts and made their legs move involuntarily even at a lower setting.The patient stated that they called and told a representative about the issue and were told that the device wouldn't do that as it was only for the bladder.The patient noted having a post-operative appointment with a representative and no reprogramming was performed, however, that a few days later the representative suggested that they decrease the setting.The patient also reported falling several times since implant, the first time following the follow up appointment but in november and then again in december.Both falls were on their right side and the ins was sensitive to the touch, hurts, and felt like something was cutting or stabbing right at that site.The patient noted relocating in december and seeing a new urologist.The new urologist recommended turning both of their implants off, which they did, and it was confirmed during the call that they were off.The patient noted they were seeing another new urologist, but their appointment wasn't until the end of april and may be pushed out due to the pandemic.The caller was redirected to their healthcare providers.No further complications were reported.Additional information was received from a manufacturer's representative (rep) indicating that the patient had called several times because programs were not giving them relief, but that they had not been made aware of the leg issue.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information received from the patient stated they turned off their implant was the action taking for the shocking since implant.The patient had not had any assistance yet and the issue has not been resolved.

Manufacturer Narrative

Continuation of d11: product id 3058, serial# (b)(6), implanted: (b)(6) 2019, product type implantable neurostimulator.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 cause was programming issue from the beginning.The patient is working with a new physician.First, the stimulation was turned off and now it is back on again.The stimulation was decreased and they still receives jolts and stimulates the legs sometimes.The patient stated the physician explained the device can do that.

• 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: 9969977
• MDR Text Key: 188035566
• Report Number: 3004209178-2020-07301
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2020

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: 02/28/2021
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 06/10/2020; 07/22/2020
• Supplement Dates FDA Received: 06/18/2020; 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 53