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

Model Number 3023

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Noise, Audible (3273)

Patient Problem Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.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 friend/family member and patient regarding a patient who was implanted with an implantable neurostim ulator (ins) for gastrointestinal/ pelvic floor.It was reported that programmer showed eos but the prior stimulator lasted 10 years, their current ins is just over 5 years old.It was reviewed over time if higher stimulation levels are needed for patient's therapy, ins batteries can deplete quicker and caller confirmed understanding that may be the normal battery depletion because patient had been using lower settings, in the 4s and 5s and they have been in the 7s.Worked with caller to synch with the ins and when they did patient expressed a noise stating it gave them a shock, they felt a strong signal going to their butt.Later pt confirmed that went away.Caller reported seeing eos.Reviewed the programmer is reading the ins we do not expect it is providing any stimulation.Patient said the patient has not had any medical tests or procedures nor had any major falls, they may have fallen a little bit in the bedroom.Caller said patient has not had a return of symptoms, they seem to be urinating.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider (hcp) to further address the issue.

• Brand Name: INTERSTIM
• 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: 18148622
• MDR Text Key: 328282766
• Report Number: 3004209178-2023-21677
• Device Sequence Number: 1
• Product Code: EZW
• UDI-Device Identifier: 00613994756558
• UDI-Public: 00613994756558
• 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: Other
• Type of Report: Initial
• Report Date: 11/16/2023

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: 03/28/2017
• Device Model Number: 3023
• Device Catalogue Number: 3023
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 11/16/2023
• Date Device Manufactured: 10/02/2015
• 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 Sex: Female