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

Model Number 3058

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211)

Patient Problem Insufficient Information (4580)

Event Date 02/24/2024

Event Type  malfunction  

Manufacturer Narrative

B3: date is approximate.Month and year are confirmed 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 gastrointestinal/pelvic floor.It was reported that starting about a couple of days ago maybe, less than a week ago, they noticed when they turned the programmer on to check how it was going, they didn't see the lightning bolt on the top left of the screen.The patient stated they pressed the top button on the programmer to get the lightning bolt to come on, but they were concerned that the therapy was turning off on its own because they'd come back later, and they would connect to their ins settings and the therapy would be off yet again.Patient services confirmed with the patient that they were currently looking at their programmer screen and they were connected to their settings.They stated the lightning bolt was present indicating the therapy was on.Patient services had the patient press the programmer off button (the blue button on the front under the light bulb).Patient services then had the patient power the programmer back on, had them hit the sync button and they were able to connect and saw the lightning bolt was still there/the therapy was still on.Patient services had the patient power the programmer off again and advised the patient to leave it off for a while and to check later and connect to their settings to see if the lightning bolt was still there.Patient stated they'd never first turned the programmer off when they were done making their therapy change and stated they'd had the device for years however and they knew not to hit the side buttons on the programmer when they were done making an adjustment.Patient denied seeing an ins low battery message at this time.Patient services reviewed it would be highly unlikely that the therapy was turning itself off but to call back if they noticed the lightning bolt was gone again when they connected to their settings and to also reach out to their managing health care provider (hcp about the issue.Patient stated they would check in an hour and call back if they saw that the therapy was off again.Patient stated they had an appointment with the hcp coming up in two weeks and they'd follow up with the hcp at time again their concerns if the issue still occurred.Documented reported event.No further action was taken by patient services.

• Brand Name: INTERSTIM II
• 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: 18815495
• MDR Text Key: 336872353
• Report Number: 3004209178-2024-06062
• Device Sequence Number: 1
• Product Code: EZW
• 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: 03/01/2024

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: 04/28/2017
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/01/2024
• Date Device Manufactured: 10/28/2015
• 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
• Treatment: SEE H11...
• Patient Age: 77 YR
• Patient Sex: Female