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

Model Number 97800

Device Problems Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Positioning Problem (3009)

Patient Problems Headache (1880); Incontinence (1928); Nerve Damage (1979); Pain (1994); Dizziness (2194); Anxiety (2328); Cramp(s) /Muscle Spasm(s) (4521); Skin Inflammation/ Irritation (4545); Insufficient Information (4580)

Event Date 11/30/2022

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel dysfunction and urge incontinence.It was reported that they had the ins for various reasons for the bladder but the biggest reason was for their interstitial cystitis (ic).They reported that since they got the implant the therapy wasn't helping their symptoms, they'd be sitting on the sofa and the "leakage would be happening" and that they have never felt the stimulation in their bike-seat, that they've always felt it down their leg and into their toes where the right toes would curl.The patient stated they would get spasms from it in their right leg and they just thought that was them and that it was "normal" until they saw a nurse and the nurse told them the stimulation should be in the bike-seat, not going down the leg and into the toes.The patient stated the nurse commented yesterday that the placement of the device was "odd" but the patient didn't know what that meant.The patient did state that they would get migraines and have dizzy spells and that they fell while they were still healing from the procedure but they still had pain from the healing process at the time so they didn't really notice a difference with the implanted system after the fall.The patient stated their hcp at the time did an x-ray and told the patient that everything was "in place" but that hcp had since left the practice so the patient was just working with the nurses at the clinic now.The patient stated the nurse was trying different settings yesterday (they thought all the different programs) but they were baffled because they couldn't find any program where the patient felt the stimulation in the bike-seat.The patient stated the nurse told them they were going to "make it wider so it would reach the bike-seat" but they were unable to find a setting that would "reach the bike seat" for the patient so they left it on program 3 at 0.3 ma.The patient stated that the nurse told them "it's not helping because it's not reaching your bladder at all".Patient services reviewed device description/function as well as therapy expectations, indications and programming and stimulation considerations with the patient.The patient stated they were concerned they could have nerve damage if they'd had pain and stimulation down the leg since they first got it.Patient services redirected the patient to continue following up with the nurse about their concerns and also brought up the possibility of a reprogramming session if that hadn't been done yet.The patient stated the nurse told the patient they were going to contact a medtronic representative to schedule an appointment where the rep could come to the clinic to check the implanted system and that the nurse was going to be calling the patient back.Patient services provided the patient with the national answering services (nas) number for the nurse to call if necessary and also sent the patient health care provider (hcp) listings at the patient's request.The patient stated they would continue following up with the nurse and that they would also potentially search for a new managing health care provider (hcp) to get a second opinion about placement.Documented reported event.No further action was taken by patient services.The patient's relevant medical history included the patient stated they had "high anxiety" and that the nurse told had told them that perhaps their anxiety was "overriding" the therapy's effect on their symptoms.

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

Upon further consideration, patient services wanted to note that even at their current low setting in certain positions they would still feel it in their toe and that they felt a spasm while on the call after moving to a new position.Patient services also wanted to note that the patient described the therapy as "irritating," and that feeling the stimulation down their leg and into their toe and having the spasms would be painful/hurt them sometimes.

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.

• Brand Name: INTERSTIM X
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• 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: 18423294
• MDR Text Key: 331768996
• Report Number: 3004209178-2024-26672
• 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: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

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: 02/28/2024
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/01/2024
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 01/03/2024
• Date Device Manufactured: 09/07/2022
• 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): Other
• Patient Age: 48 YR
• Patient Sex: Female