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); Failure to Interrogate (1332); Energy Output Problem (1431); Application Program Problem (2880); Communication or Transmission Problem (2896); Insufficient Information (3190)

Patient Problems Incontinence (1928); Insufficient Information (4580)

Event Date 08/04/2022

Event Type  malfunction  

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

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for fecal incontinence and urina ry/bowel dysfunction.It was reported that caller stated they don't know if the device is working because they are still having problems.Caller stated it has been quite a while since the device was adjusted.Both handset and communicator needed to be charged.Patient will charge external equipment and call back for further assistance connecting to ins.The patient called back with the external pieces charged.They stated they needed assisting in "calibrating" the ins because they were not able to get to the bathroom in time and that they were urinating.Patient services had the patient pair the communicator with the handset.The communicator paired immediately but the patient was unable to communicate with the ins.The patient initially couldn't feel where the ins was and even stated they had no clue where it was they had it for so long but didn't know where it was, but then stated they felt it and despite all troubleshooting steps taken, the patient still saw device not responding.The troubleshooting steps taken on the call did not resolve the reported issue.Patient services wanted to note that the patient became very escalated upon receiving the first 'device not responding' screen, and it was difficult to communicate with the patient to troubleshoot.Towards the end of the call, the patient me ntioned to patient services that they hadn't used their communicator in a long time.They stated their medtronic representative "chase" had told them to set it in a drawer and forget it so they had.They stated they thought the communicator would stay charged for 5 years.Reviewed information with the patient as well as best practices for communicator maintenance and an email was sent to repair to replace the communicator.Patient services reviewed with the patient to follow up with their managing health care provider (hcp) to check their implanted system if the replacement communicator did not resolve their inability to connect to their ins.Additional information was received from the patient.Patient called in because they were on program 3 at 0.2 and when they try to increase stim they get the max settings message.Patient was also getting the max settings message on program 4 at 0.3, program 5 at 0.3 and program 6 at 0.3.Patient noticed this today as they just received the new communicator.Patient said they are not going all over themselves quite as bad.Patient was not able to feel stim on any of the programs.Patient said the hcp gave them contact info for reps.Patient said one of them had a full vm and the other didn't return the patient's call.Reopened and reassigned case to email the reps.

• 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: 18699128
• MDR Text Key: 336408218
• Report Number: 3004209178-2024-04623
• Device Sequence Number: 1
• Product Code: EZW
• 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
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 01/26/2024
• Initial Date FDA Received: 02/13/2024
• 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
• Treatment: "SEE H11...."
• Patient Age: 66 YR
• Patient Sex: Female