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 Deliver Energy (1211); Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Communication or Transmission Problem (2896)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2021

Event Type  Injury  

Event Description

Information was received from a manufacturer representative (rep) and a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor.It was reported that sometime in (b)(6) 2021 the neurostimulator started to come out of the pocket and patient had a revision to place the ins deeper sometime in (b)(6) 2021, the patient said can't remember dates.Patient stated that on day of surgery patient forgot to bring her equipment and was told by the manufacturer representative (rep) that they will use their programmer to program.Patient said that sometime in december towards the end, they started to experience that something didn't feel right. patient is just connecting today for the first time and unable to connect and is receiving the message: different internal device detected.Patient said that she was not notified that the ins was replaced and there wasn't any updates sent regarding new device, only the device from (b)(6) 2021.Because of this message patient is unable to connect to check any device data and will need to be seen in office to correct.The rep stated that the patient was scheduled last week and did not have a new battery, just a pocket revision.The rep stated the device was not eroding, the patient could feel it and wanted it deeper.Patient was supposed to have an mri and will not be able to do so as a result. the patient was redirected to their healthcare provider to further address the issue.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

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

Additional information was received from rep.They reported that they have contacted patient several times, and have only answered once.Patient has not showed to several appointments that were set up with them at the hcp office.

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

Additional information was received from the patient.They reported that they need to have a mri and when they try to connect w/ the ins they see a message that say wrong internal device detected.Patient started seeing this message in july or aug of 2021 when they tried to adjust stim because they weren't feeling anything.The caller was redirected to rep.The patient mentioned the previous report of when implanted had come out of the pocket and had to be implanted deeper.Patient didn't bring their external devices to the procedure.The rep was going to reach out to the patient.

Event Description

Additional information was received: the patient called back and repeated previous events regarding pocket revision.They met with their manufacturer representative (rep) but were unable to get the handset to work.The patient was not clear in specifying the exact nature of the problem.First they were seeing device not found, then they saw different internal device detected, and then they said that the actual issue is that they are encountering device not responding.The rep had the patient lean over a table and positioned the handset over the ins but it still was not communicating to the ins.The patient was escalated and very difficult to engage in troubleshooting.They repeatedly said that the rep told them to request a replacement handset.It was reviewed with the patient that a replacement handset may not resolve the problem depending on the root cause.The patient plans to follow up with the rep upon receiving a replacement handset.A new handset was sent to the patient to resolve the issue.The rep called back and requested that the handset be sent to the patient per the reported telemetry issues.They indicated that the patient was upset about the process and told the rep that they were not going to get a replacement handset.It was reviewed with the rep that a request had already been sent to have the new handset sent to the patient.The rep planned to follow-up with the patient.

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.

• 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
• 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: 13569794
• MDR Text Key: 289778354
• Report Number: 3004209178-2022-02312
• 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: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/24/2022

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: 01/31/2022
• Initial Date FDA Received: 02/21/2022
• Supplement Dates Manufacturer Received: 02/24/2022; 03/07/2022; 05/19/2022
• Supplement Dates FDA Received: 02/28/2022; 03/31/2022; 05/24/2022
• Date Device Manufactured: 10/09/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female