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

Model Number 3058

Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Neuropathy (1983); Pain (1994); Urinary Retention (2119); Distress (2329); Discomfort (2330); Ambulation Difficulties (2544); Constipation (3274); Insufficient Information (4580)

Event Date 01/01/2023

Event Type  Injury  

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor therapy and fecal incontinence.It was reported that they were getting a lot of pain down the legs, abdomen, and back and they were not sure if the interstim was working right or working at all.Patient explained they had a history of back surgery with rods and screws and recently had ct scan and everything was fine and the interstim components were intact so patient was trying to understand what was causing the pain and wondering if it could be related to the interstim.Patient recently went to the hospital, and they were saying patient has neuropathy and are trying to tell patient it is nerve pain but patient does not think its nerve pain.Patient could not walk from the pain.Therapy was on and patient had turned it up some and does not think the pain got worse after increasing but was hoping it could help the pain.Discussed patient had interstim indicated for fecal incontinence but patient reported they have both bladder and bowel symptoms.Patient services reviewed expectations and indications of interstim therapy.Patient said they got retention sometimes because they have ibd and can tell they don¿t release a lot of urine due to constipation.Patient also mentioned history of prolapsed bladder.Patient also reported the ins battery site was uncomfortable after losing 30 pounds in the last 3 months.The patient also reported the lead wire is surfacing.It had not come through the skin but can see it very easily and it is sensitive to the touch.Patient implanting physician has passed away and has no managing physician.Patient services encouraged patient to follow up with a trained interstim physician and provided physician listings.Reviewed option to turn therapy off or decrease stimulation to see if pain symptoms are impacted.

Manufacturer Narrative

Continuation of d10: product id: 978b128, lot# va2a0l9, implanted: (b)(6) 2020, product type: lead.Section d information references the main component of the system.Other relevant device(s) are: product id: 978b128, serial/lot #:(b)(6), ubd: 30-jun-2022, udi#: (b)(4).B3: event date is not known.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.

Manufacturer Narrative

Continuation of d10: product id 978b128, lot# va2a0l9, implanted: (b)(6) 2020, product type lead.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Information was received from a patient (pt) with an implanted neurostimulator (ins) for gastrointestinal/pelvic floor therapy and fecal incontinence.They reported that, starting last year, they noticed back pain, pain where the battery pack is and the wire around it protrudes out of their skin a little bit more some days more than others.Pt said they were in so much pain they spent several days in the hospital where they did a ct and saw the wire around the casing.Pt was calling medtronic due to a handset issue, stating they can't even turn therapy off.Troubleshooting did not resolve handset issue, an email was sent to repair to replace the handset.Pt was redirected to their doctor.Pt said they finally found a new one doctor and will have an appointment coming up.Additional information was received from the patient.The patient followed up asking for help on how to connect their handset to their communicator and ins.Agent walked the patient through setup and showed the patient where stimulation can be adjusted.Device troubleshooting resolved the issue.The patient also mentioned that the device was causing them pain and that they felt like the wire was protruding from their skin.Patient was also frustrated they expressed "i want it out, i want it out, i want it out." lastly, the patient followed up on physician listings issue and wanted to ask if their hcp was medtronic healthcare provider.

• Brand Name: INTERSTIM II
• 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: 18924095
• MDR Text Key: 337904766
• Report Number: 3004209178-2024-07278
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2024

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: 03/28/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 05/06/2024
• Date Device Manufactured: 09/29/2020
• 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
• Treatment: "SEE H11...."
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female