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

Model Number 3058

Device Problems Failure to Deliver Energy (1211); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problem Incontinence (1928)

Event Type  Injury  

Manufacturer Narrative

B3: event date is not known.Please see b5 for approximate date range, if applicable.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 (pt) regarding an implantable neurostimulator (ins) for the treatment of bowel issues.It was reported that after getting interstim, it was working great to improve their bowel symptoms, but starting about 6 months after the implant, they needed to change the program, and that worked for a short time.Then they made another change, and that worked for a short time, but they started carrying pads and wearing diapers.Pt said if they increased too far, they had tingling where they should not have tingling.Pt said they were calling medtronic today because, off and on for the past week, they noticed an intermittent beeping sound they think is coming from their stimulator, and they are worried the battery died.The patient said dr.Michael freeman is no longer there, and they called a new urologist office.They were told interstim supports them, but the office told the patient that all they could do was help them turn it off and they needed to call medtronic.Pt said no matter what room they are in, in their house, they hear the beeping; it even woke them up; however, the beeping was not heard during the call.The reviewed patient has the option to turn therapy off to monitor if they hear the noise or not.They reviewed information about the low ins battery indicator message on their equipment and offered to assist the patient to synch with their ins to check and potentially turn therapy off.Pt was successful in synching with their ins, changed their program, and turned therapy off.Pt wanted therapy on, turned it back on, and adjusted to a comfortable setting.Further discussion revealed the patient was using the stim off button accidentally and may possibly have been turning therapy off prior to today.Pat agent reviewed some interstim education and programmer information and offered and sent quick guide and doctor listings.They were redirected to their doctor.The patient will maintain stimulation levels and will continue to track symptoms.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received from the patient.It was reported that the patient had an appointment scheduled with their new hcp for 04/01/2024.Patient stated they will likely be getting a new implant and possibly wires.The patient added that the cause of the noise heard was determined to not be coming from their implanted device.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received from the patient.They reported that they have schedule a surgery to replace the outdated unit and the device replaced has been planned.

• 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: 18644519
• MDR Text Key: 334883100
• Report Number: 3004209178-2024-03614
• 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: 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,Followup,Followup
• Report Date: 06/26/2024

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: 10/28/2018
• Device Model Number: 3058
• Device Catalogue Number: 3058
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 04/05/2024; 06/11/2024
• Supplement Dates FDA Received: 04/29/2024; 06/26/2024
• Date Device Manufactured: 05/11/2017
• 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 Sex: Female
• Patient Weight: 64 KG