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

Model Number 97800

Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431); Overheating of Device (1437); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Incontinence (1928); Pain (1994); Burning Sensation (2146)

Event Date 02/03/2023

Event Type  Injury  

Event Description

Information was received from a friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence and urinary/bowel dysfunction.It was reported that the patient has the ins for both urinary and bowel control and they have been gradually increasing stimulation since implant.Last friday they noticed that a partial loop of the lead came through the incision and patient had a procedure to bury it back under the skin on tuesday of this week.Later that evening the patient increased stimulation from 2.7 to 2.9 and patient felt a flutter but it was stronger and more prolonged than usual and patient also felt the ins site heat up.The caller also reported it felt warm to the touch.Caller reported there is no swelling present but it is somewhat painful however they believe this is due to post operative healing.The caller reported they turned the stimulation back down which resolved the heating sensation and patient is no longer feeling stimulation sensation either.Patient had an appointment today with a nurse but did not speak with the physician.Caller believes they told the nurse about the symptoms and she recommended they contact the manufacturer representative.The caller was wanting to know if they could increase stimulation again to optimize therapeutic effect.Caller reported the patient is getting at least 50% reduction of baseline symptoms but it is hard to tell because patient's symptoms are variable.Caller reported some nights it controls urine pretty well and patient has not had much bowel issues either.Caller reported the patient only had one bowel accident after implant but they believe it was because the stimulation had not been turned up high enough yet.Recommended the patient follow up with managing physician to further assess their symptoms.Caller confirmed they will contact managing physician office and requested to get in touch with field staff as well.

Manufacturer Narrative

Concomitant medical products: product id: 978b128, lot#: va2q9g7, implanted: (b)(6) 2023, product type: lead.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(4), ubd: 24-apr-2024, udi#: (b)(4).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.

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 a manufacturer representative (rep) and a healthcare professional (hcp).The rep reported that they ran an impedance test on this patient's stimulator, no impedances were detected.The patient has been using their ins at 2.5 milliamps with not problems.The rep increased the stimulation up to 2.6 and the patient could feel the stimulation at a comfortable level.The patient did not feel as though their skin was warm when turned up to 2.6.The patient will keep their stimulation level at 2.6 and continue to use their remote to make any adjustments.The hcp reported it is unknown if the cause of the partial loop of the lead coming through the incision was determined.The issue was resolved with surgery.It is unknown if the cause of the ins heating up was determined.The issue was resolved with a lead impedance check and stimulator reprogramming.The cause of the patient not feeling stim after turning it down was determined.The issue was resolved with reprogramming and education.

• Brand Name: INTERSTIM X
• 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
• 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: 16364382
• MDR Text Key: 309414631
• Report Number: 3004209178-2023-02002
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00763000484668
• UDI-Public: 00763000484668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

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: 04/28/2024
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 02/13/2023
• Supplement Dates Manufacturer Received: 02/13/2023
• Supplement Dates FDA Received: 03/14/2023
• Date Device Manufactured: 10/28/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female