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

Model Number 97800

Device Problems Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pain (1994)

Event Date 04/17/2023

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id: 978b128, lot# va2qphg, implanted: (b)(6) 2023, explanted: product type: lead.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

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for urinary/bowel disfunction and urge incontinence.It was reported that the patient had called to inquire about how to use their therapy as they went to see their managing health care provider and the hcp didn't know anything about the device.The patient stated they'd never had the therapy activated as a result.The patient stated about two months after they were implanted they went to their primary care physician, who told them when they were inspecting the patient's whole body that they had a wire sticking out of their back and that it was from the implanted bladder stimulator.The patient stated they were paralyzed from the nipples down so they hadn't felt anything and hadn't realized a wire was sticking out.The patient stated the doctor had the patient feel the wire and the patient stated they felt it and it felt like a thin wire sticking out that the patient could move back and forth.The doctor took some surgical tools and cut the wire.Patient services reviewed device description/function with the patient and redirected the patient to follow up with an hcp to inspect the implanted system.Patient services sent the patient hcp listings at the patient's request but the patient wanted instruction on how to connect to see their settings.The patient's caretaker was with the patient and patient services walked them through connecting to see the patient's settings.The therapy was on, on program 3 at 6.5 ma and the patient did not feel the stimulation even when the stimulation was increased to above 7 ma.Patient services reviewed with the caller that if the patient's wire was cut that they should turn the therapy off until they saw an hcp as the battery being on without the wire connected would just be draining the ins battery.Patient services wanted to note that when the patients caretaker was repositioning the patient to connect to the patient's settings, they stated that the patient was in a lot of pain but couldn't say if the pain was from the patient's bladder stimulator or another stimulator that the patient had in their back.Patient services sent the patient physician listings and the patient was going to follow up with an hcp.

• 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: 18277073
• MDR Text Key: 329856788
• Report Number: 3004209178-2023-25292
• Device Sequence Number: 1
• Product Code: EZW
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/06/2023

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: 11/14/2023
• Device Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/06/2023
• Date Device Manufactured: 05/21/2022
• 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 Age: 67 YR
• Patient Sex: Male