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

Model Number 3058

Device Problems Display or Visual Feedback Problem (1184); Failure to Interrogate (1332); Malposition of Device (2616); Communication or Transmission Problem (2896); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

Event date: event date is approximate (month and year valid).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 dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that the patient noticed "a few days after" the date of implant that the ins was "too shallow," so on december 23rd, they had the ins repositioned to a deeper position.On the date of repositioning the ins, they forgot to bring their programmer with, so the healthcare provider connected with the patient's ins with their clinician programmer to turn it back on.Since then, now when the patient tries to connect with their ins using the communicator/handset, they were getting the error message "different device detected.Different internal device detected.Reposition communicator over the correct device".They continued to get this message despite pressing retry, and confirmed they only had one ins and they have the same ins that was only positioned deeper.The patient was walked through pressing retry on the call and they reported getting the device not responding message.They confirmed the communicator was placed directly on the ins.They repositioned the communicator over the ins and pressed retry and then received the "different device detected" message again.They continued to get the "different device detected" message on the call despite pressing retry/end session, closing out/re-opening the patient application, and powering off/on communicator.They were redirected to their healthcare provider to discuss and further address the issue.It was reviewed the healthcare provider could request a manufacturer representative be at the appointment.The issue was not resolved through troubleshooting.

Manufacturer Narrative

B3 correction: updated to 2020-11-04, date 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.

Manufacturer Narrative

H6: previous fdd code (a1502) updated to a150202.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

Additional information was received from the patient.They reported that they had contacted the doctor who manages their device about the "different device detected" error message and inability to communicate with the ins.When asked to clarify the report they had noticed "a few days after" the date of implant that the ins was "too shallow," they responded the placement issue was during implant.The cause of the issue was reportedly determined.When asked what most likely caused or contributed to the issue, they replied the placement issue was during implant surgery, and surgical revision was done on (b)(6) 2020.The cause of the, "different device detected.Different internal device detected.Reposition communicator over the correct device," message was reportedly determined.When asked what most likely caused or contributed to the issue, they replied when they had surgery again to revise the placement, they forgot their controller, so they used theirs and it had to be reprogrammed back to the patient's.When asked what steps were taken to resolve the issue, they stated they had a follow up appointment and they reprogrammed their controller to work.The issue was resolved.The cause of the inability to communicate with their ins was reportedly resolved.When asked what most likely caused or contributed to the issue, they responded they had surgery on (b)(6) 2020 to revise the placement and forgot their controller, so they used their own and it messed up their controller's communication with the device.The issue was resolved in-office.

• Brand Name: INTERSTIM II
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 11166851
• MDR Text Key: 227949425
• Report Number: 3004209178-2021-00718
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994913654
• UDI-Public: 00613994913654
• Combination Product (y/n): N
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2021

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: 01/14/2022
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 05/19/2021; 05/19/2021
• Supplement Dates FDA Received: 05/19/2021; 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 88