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); Energy Output Problem (1431); Unstable (1667); Application Program Problem (2880); Material Deformation (2976)

Patient Problems Abdominal Cramps (2543); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2023

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id: 978b128.Lot#: va2qkk4.Serial#: implanted: (b)(6) 2023.Explanted: (b)(6) 2023.Product type: lead section d information references the main component of the system.Other relevant device(s) are: product id: 978b128, serial/lot #: va2qkk4, ubd: 24-apr-2024, udi#: (b)(4).B3: date is estimated; month and year are valid.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 dysfunction and fecal incontinence.It was reported that they had return of symptoms.Patient said that about the last week or two, they started to experience cramping in the stomach and as a result has been eating less frequently.Patient said that also noticed a return of bowel symptoms around the same time frame.When asked, no recent medical tests or procedures, no falls.Patient mentioned that has been prescribed budesonide medication to help treat the cramping.Patient tried to make an adjustment today however they received message that the system is operating at the maximum setting and therapy cannot be increased.When asked, patient said that the last adjustment made was about a month to a month and a half ago.Patient services reviewed option to decrease the setting and then try to increase from there however patient when tried patient received the same message.Patient said has switched to different programs and couldn't increase beyond.5 on any of the program.During the call patient switched to a different and said that the setting was now at 0.1, however received the maximum settings message at 0.5.The issue was not resolved through troubleshooting.The patient was re directed to their healthcare provider to schedule reprogramming session.Other medical history mentioned that patient has an immune condition unable to fight off bacteria and gets pneumonia and bronchitis twice a year and is schedule for immune therapy infusion treatment.Additional information was received from the healthcare provider (hcp) and the patient.They stated the ins flipped in the pocket.This caused a loss of stimulation.The lead was curled/twisted but intact with the ins.They stated the cause was determined to be poor tissue quality.The issue was resolved with device replacement.The battery flipping was determined to be the cause of the maximum settings message.

• 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: 17755990
• MDR Text Key: 323508664
• Report Number: 3004209178-2023-15944
• 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: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/15/2023

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 Model Number: 97800
• Device Catalogue Number: 97800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/15/2023
• Date Device Manufactured: 12/14/2022
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 121 KG